Position Summary:
The Data Steward II position at CAPS is responsible for implementing and continuously improving the Site Data Integrity Program. This role requires maintaining a comprehensive knowledge of data integrity quality and regulatory requirements, identifying compliance risks, and developing solutions to address those gaps. The Data Steward will coordinate the quality, security, and maintenance of data to ensure compliance and support business processes effectively.
Quality Assurance department
Responsibilities: Essential Duties
Implement and continuously improve the Site Data Integrity Program.Maintain knowledge of applicable data integrity quality and regulatory requirements.Identify data integrity compliance risks and gaps across the site.Communicate risks to Site Management and develop solutions to address gaps.Coordinate the quality, security, and maintenance of data.Create data process mapping and risk reduction efforts for data owners and Quality representatives.Define data elements and establish policies and procedures related to data collection and accuracy.Perform tests and audits on data systems to ensure data quality.Create methodologies and metrics for tracking performance to Data Integrity expectations.Act as system administrator for manufacturing and laboratory systems.Support implementation of electronic software and systems.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.
Expertise: Knowledge & Skills
Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.Work under minimal supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, and/or reviewing the work of peers.Judgement is required in resolving complex problems based on experience. Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.
Expertise: Qualifications -Education/Experience/Training/Etc
Required:
Bachelor's degree required.04-06 years related experience required.Occasional business travel required, Valid driver's license and passport
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
Physical Demands:
While performing the duties of this job, the employee is expected to:
Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.Lifting, Carrying, Pushing, Pulling and Reaching:
Occasionally:Reaching upward and downward, Push/pull, StandFrequently:Stand,SitConstantly:N/AActivities:
Occasionally: Push/pull, Reaching upward and downward, Standing, WalkingFrequently:Finger feeling, Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Talking - ordinary, loud/quickConstantly:N/AEnvironmental Conditions:
Occasionally:N/AFrequently:N/AConstantly:N/AWork Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Noise Intensity: LowOccasionally: Production/manufacturing environmentFrequently:N/AConstantly:Office environment
Base Salary: $95,615 - $120,096
PIeed816e74ad8-5984
Read LessB. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS .
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit
CAPS , the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation's largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
CAPS is part of the B. Braun Group of Companies in the U.S.
Position Summary: Monday Friday 6:30am - 3pm
Ensure site-specific compliance with CAPS Standard Operating Procedures (SOPs).
Responsibilities: Essential Duties
Perform and review the Daily Compliance Verification Checklist, document results, and report to immediate supervisor.Perform and/or coordinate completion of:Environmental monitoring and documentation e.g. personnel monitoring, air bioburden, surface bioburden, temperatures, and particle countsCollect Environmental Monitoring samples as necessaryNew staff trainingSterility tests, aseptic technique qualifications, and media fill process validations.Perform Document review of anticipatory and as appropriate non-sterile to sterile compounding batch records:Verify that raw materials meet specification limitsVerify accuracy of labelingPerform final disposition of BatchVerify that product test results meet specification limitsVerify that all documentation is completeDocument non-compliance and evaluate if further investigation is neededSubmit samples to the appropriate labs for chemical assay and microbial tests.Track vendor equipment calibration and maintenance records and assess for deviations.Enter test results or summaries into the pharmacy specific monthly and quarterly Quality Assurance report template.Under the direction of supervisor, document results of deviation and complaint investigations, causal analysis, corrective actions and preventive actionsSupport Internal & External audits.Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).Participate in Director of Pharmacy's staff meetingsExpertise: Knowledge & Skills
Knowledge of pharmacy operations and regulatory guidelines.Ability to perform pharmacy calculations. Responsibilities: Other DutiesAs assigned by immediate supervisor.Expertise: Qualifications - Experience/Training/Education/Etc
Required:
B.S. or B.A. degree in Science (Biology, Microbiology, Chemistry, Pharmacy)Minimum of 2 years experience in a QC/QC department of a pharmaceutical or Allied Health Science.As assigned by Supervisor.Desired:
Minimum of 2 years experience in pharmacy preparation.Pharmacy Technician Certification.While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
Physical Demands:
Some travel may be required.Ability to stand and/or sit for long periods of time.Ability to reach, grasps, stoop, pull and perform repetitive motion procedures.Ability to lift up to 20 lbs.The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work Environment:
Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
Salary Range:$22.76-$28.45
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at .
Through its "Sharing Expertise " initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here .
Compensation details: 26.41-26.41 Hourly Wage
PI054fb78a5-
Read LessB. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS .
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit
Position Summary:
Responsibilities: Essential Duties
Plans and organizes chemical analysis of starting material, in process and finished product and stability studies and ensure adherence to approved test methods, specifications, procedures, equipment operating instruments and guidelines.Responsible for the overall system of compilation, preparation and release of test results/ reports.Conducts chemical analysis and experiments to develop new knowledge, materials, processes and products.Analyzes samples from various sources to provide information on different materials.Develops new techniques to analyze chemicals.Collaborates with specialists to interpret data and writes reports about the results.Analyzes test information to determine process efficiency and works on improvements.The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
General:
It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons.
Knowledge and Skills Requirements:
Requires full working knowledge of relevant business practices and procedures in professional field.Uses standard theories, principles and concepts and integrates them to propose a course of action.Supervision Given and Received:
Works under general supervision.Relies on experience and judgement to plan and accomplish assigned goals.May periodically assist in orienting, training, assigning & checking the work of other peers.Expertise: Qualifications - Experience/Training/Education/Etc
Required:
Bachelor's degree required04-06 years related experience required.Ability to work non-standard schedule as neededWhile performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
Physical Demands:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential duties of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is expected to:Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.
Lifting, Carrying, Pushing, Pulling and Reaching:
Occasionally:Reaching upward and downward, Push/pullFrequently: Stand, SitConstantly: N/AActivities:
Occasionally: Hearing - ordinary, fine distinction, loud (hearing protection required), Push/pull, Reaching upward and downward, Talking - ordinary, loud/quick, WalkingFrequently: Handling, Sitting , StandingConstantly: N/AEnvironmental Conditions:
Occasionally: Exposure to toxic or caustic chemicals (in most areas)Frequently: N/AConstantly: N/AWork Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Noise Intensity: ModerateOccasionally: Production/manufacturing environmentFrequently: N/AConstantly: Lab environmentSalary Range:$65,302.00 - $81,628.00
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at .
Through its "Sharing Expertise " initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here .
Compensation details: 8 Yearly Salary
PIcc6bc72a7ba2-9117
Read LessB. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS .
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit
CAPS , part of the B. Braun Group of Companies in the U.S., is the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation's largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
CAPS , part of the B. Braun Group of Companies in the U.S., is the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation's largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
Position Summary:
Ensure and assist with site-specific quality compliance according to CAPS Standard Operating Procedures (SOPs) & specifications, quality review of documents, label control, assist with release activities and product inspections.
Essential Duties/Responsibilities:
Perform product inspection for defects, leaks and particulates.Perform environmental monitoring of personnel (as needed) and complete documentation.Assist in the media fill process validations to include inspection of filled unitsPerform document review of compounding activities such as cleaning records, line clearance forms and inventory sheets:Verify that raw materials meet specificationVerify and account for labelingReview temperature and BMS alarmsVerify that product test results meet specification limitsVerify that all documentation is completeDocument non-compliance and work with supervisor/lead if further investigation is neededSubmit samples to the appropriate lab for particulate identification or microbial analysis.Assist with equipment calibration program and maintenance record files.Assist with raw material release and movement.Under the direction of supervisor/lead, document and initiate quality events for deviation and complaint investigations.Support internal & external audits.Maintain quality records (equipment calibration and maintenance, training, deviation and complaint investigation, environmental monitoring, Certificate of Analysis, clean room certification etc.).Participate in Quality Manager's staff meetings
Expertise: Knowledge & Skills
Knowledge of pharmacy operations and regulatory guidelines.Ability to perform calculations.Ability to work within established procedures and practicesStrong organizational skills and attention to detailAbility to effectively troubleshoot issues.
Qualifications - Experience/Training/Education/Certification/Etc:
Required:
Minimum of High School Diploma/GED with work experienceMinimum of 2 years experience in a quality or manufacturing department of a pharmaceutical, Medical Device or Allied Health Science. Schedule (2nd shift) Monday-Friday 2:30-11:00PM
Desired:
Experienced in aseptic operations.Experience within a regulated environmentAssociates Degree or higher level degree in Technician technical scientific discipline, Biology, Microbiology, Chemistry or Pharmacy.While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 45 pounds.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
Physical Demands:
The employee must occasionally lift and/or move up to 45 pounds.The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Work Environment:
Indoors, cleanroom, working environment limited to a small area, wearing protective cleanroom attire, tolerating controlled temperatures and loud noise.The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. The noise level in the work environment is usually moderate.
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at .
Through its "Sharing Expertise " initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here .
PI471b3921bdb0-0281
Read LessB. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS .
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit
CAPS , part of the B. Braun Group of Companies in the U.S., is the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation's largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
Position Summary:
Performs routine functions/analysis as required by the laboratory in compliance with CAPS, and cGMP specifications. The analyst prepares test samples and performs tests according to the standard operating procedures.
Responsibilities: Essential Duties
Perform routine analysis of finished product, raw material or environmental samples according to established specifications and procedures using various laboratory apparatus under minimal supervision of senior staff.Interprets and applies specifications and operating procedures when carrying out both monitoring and testing responsibilities.Records data in controlled notebooks, controlled data sheets, validated spreadsheets and/or LIMS including all computational tasks and completes analysis report forms. Maintains neat and legible records and promptly and accurately inputs data into LIMS.May perform routine laboratory maintenance and instrument upkeep as required. Prepares standards or test reagents according to established procedures and specifications.Follows cGMPs, GLPs, SOPs, USP and FDA guidelines in all appropriate functions and notifies supervisor and/or lead of any observed discrepancies.Prepare media, reagents, test samples and equipment as required. Responsible for the general cleanliness and appearance of the lab by keeping laboratory equipment, supplies and environment in good operational condition.Proficient or become proficient in Environmental Monitoring techniques.Proficient or become proficient in Sterility Test, Bioburden, and Growth Promotion.Proficient or become proficient in Bacterial Endotoxins testing using Kinetic-Turbidimetric assay.Keep inventory of laboratory supplies for routine testing and special projects.
Expertise: Knowledge & Skills
Understand aseptic technique.Knowledge of basic chemistry principles in the quality field.Must have a good understanding of documentation procedures and GMPs for the health care industry.Good communication and interpersonal skills.Ability to work independently or in a team. Good technical and troubleshooting skills.Must be able to use computers, calculators, diagnostic test equipment and precision measuring equipment.Must have organizational planning skills.Excellent communication skills.Must be able to get along with the other people and work as a team member.Must be able to follow instructions and follow tasks through to completion.Must be flexible/adaptableMust be able to schedule tasks and meet deadlines.Must be able to manage one's time and have a sense of urgency.
Required:
Bachelors degree and 2-3 years related experienceBasic understanding of Chemistry; basic knowledge in technical area as required by the specific QC lab.Basic knowledge of good analytical and laboratory techniques, basic knowledge of cGMPS's, GLP's, SOP's, USP, and FDA requirements.Frequent travel required.Apply specific skills as required by the technical specialty(s) within the department.Desired:
Science degree and direct experience in specific laboratory work.
Schedule is (8am-5pm) Monday-Friday. Weekends, holidays, and overtime as needed
Salary range is $21.18-$25.42
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at .
Through its "Sharing Expertise " initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here .
Compensation details: 21.18-25.42 Hourly Wage
PIc934cbf2dbd0-7869
Read LessB. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS .
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit
CAPS , part of the B. Braun Group of Companies in the U.S., is the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation's largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
Position Summary:
Responsibilities: Essential Duties
• Manages the quality control activities of an organization.
• Assists with overseeing tasks associated with inspecting and testing products.
• Ensures that products or services meet quality standards and develops corrective action when needed.
• Develops, implements and assesses processes and policies designed to test products and services.
• Monitors and evaluates current testing processes, making recommendations for improvements when necessary.
• Enforces regulatory compliance.
• Conducts visual and physical inspections of company products and materials.
• Monitors the performance of the quality control staff, ensuring that the quality control department meets organizational objectives.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons."
Expertise: Knowledge & Skills
Requires advanced knowledge of professional field and industry. Influences the development of and drives the application of principles, theories, concepts. Determines best course of action.Manages entry to intermediate level employees of a department or a function with 1 or 2 sections. Ensures budgets, schedules, and performance requirements are met.Judgement is required in resolving complex problems based on experience.Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.
Expertise: Qualifications -Education/Experience/Training/Etc
Required:
Bachelor's degree required.06-08 years related experience required.Regular and predictable attendanceOccasional business travel required, cGMP experience/training required, Aseptic processing training/experience desired.Schedule is Monday - Friday, 7:30am - 4:00pm, with additional hours as needed. Holidays/Overtime as neededSalary range is $98,483-$123,096/year
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
Physical Demands:
While performing the duties of this job, the employee is expected to:
Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.Lifting, Carrying, Pushing, Pulling and Reaching:
Occasionally:N/AFrequently:Stand, SitConstantly:N/AActivities:
Occasionally:Finger feeling, Push/pull, Reaching upward and downward, Sitting , N/AFrequently:Hearing - ordinary, fine distinction, loud (hearing protection required), Seeing - depth perception, color vision, field of vision/peripheral, Sitting , Standing, Talking - ordinary, loud/quick, WalkingConstantly:N/AEnvironmental Conditions:
Occasionally:N/AFrequently:N/AConstantly:N/A
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Noise Intensity:ModerateOccasionally:Production/manufacturing environmentFrequently:Lab environmentConstantly:Office environment
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at .
Through its "Sharing Expertise " initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here .
Compensation details: 96 Yearly Salary
PI6a8ce24e5-
Read LessB. Braun Medical Inc., a leader in infusion therapy and pain management, develops, manufactures, and markets innovative medical products and services to the healthcare industry. Other key product areas include nutrition, pharmacy admixture and compounding, ostomy and wound care, and dialysis. The company is committed to eliminating preventable treatment errors and enhancing patient, clinician and environmental safety. B. Braun Medical is headquartered in Bethlehem, Pa., and is part of the B. Braun Group of Companies in the U.S., which includes B. Braun Interventional Systems, Aesculap and CAPS .
Globally, the B. Braun Group of Companies employs more than 64,000 employees in 64 countries. Guided by its Sharing Expertise philosophy, B. Braun continuously exchanges knowledge with customers, partners and clinicians to address the critical issues of improving care and lowering costs. To learn more about B. Braun Medical, visit
CAPS , part of the B. Braun Group of Companies in the U.S., is the nation's largest network of outsourcing admixture pharmacies, has been delivering high-quality, same-day, admixture services and solutions to hospitals and outpatient facilities for more than 28 years. Along with the nation's largest 503A sterile injectable outsourcing network, CAPS offers industry-leading batch compounding on a national scale through three 503B registered outsourcing facilities. With experience, capacity, and a passion for safety, CAPS is your 503B solution.
Position Summary:
Responsibilities: Essential Duties
• Supervises workers and tasks within the quality assurance function of an organization.
• Supervises audit or inspection processes meant to monitor compliance with established quality standards.
• Coordinates and reviews the work of a team of analysts or inspectors that collect data identifying potential quality failures, evaluate quality of raw materials or components, in progress goods, processes or operations.
• Assists team members in interpreting quality standards.
• Summarizes team findings and prepares reports for management.
• Suggests changes to vendors or purchasing/production procedures with the goal of improving processes or products.
The job function listed is not exhaustive and shall also include any responsibilities as assigned by the Supervisor from time to time.
General: It shall be the duty of every employee while at work to take reasonable care for safety and health of himself/herself and other persons."
Expertise: Knowledge & Skills
Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles and concepts and integrates them to propose a course of action.Provides direct or indirect supervision to a group of employees, assigning tasks and checking work at frequent intervals. Accountabilities include work and people scheduling, performance management and recommendations for hiring decisions.Judgement is required in resolving complex problems based on experience.Contacts are primarily with department supervisors, leads, subordinates, and peers. Frequent contact with external contractors/vendors.
Expertise: Qualifications -Education/Experience/Training/Etc
Required:
Bachelor's degree required.02-04 years related experience required.Applicable industry/professional certification preferred.Regular and predictable attendanceAbility to work non-standard schedule as neededcGMP training/experience required.
Salary Range: $71,832.00 - $89,795.00
While performing the duties of this job, the employee is regularly required to sit and talk or hear. The employee frequently is required to use hands to handle or feel and reach with hands and arms. The employee is occasionally required to stand and walk. The employee must occasionally lift and/or move up to 20 pounds.
Responsibilities: Other Duties:
The preceding functions have been provided as examples of the types of work performed by employees assigned to this position. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed in this description are representative of the knowledge, skill, and/or ability required. Management reserves the right to add, modify, change or rescind the work assignments of different positions due to reasonable accommodation or other reasons.
Physical Demands:
While performing the duties of this job, the employee is expected to:
Light work - Exerting up to 20 lbs of force occasionally, and/or up to 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects.Lifting, Carrying, Pushing, Pulling and Reaching:
Occasionally:Reaching upward and downward, Push/pull, Visual Acuity with or without corrective lensesFrequently:SitConstantly:N/AActivities:
Occasionally:Push/pull, Reaching upward and downward, Seeing - depth perception, color vision, field of vision/peripheralFrequently:Sitting , Standing, Talking - ordinary, loud/quick, WalkingConstantly:N/AEnvironmental Conditions:
Occasionally:N/AFrequently:N/AConstantly:N/AWork Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Noise Intensity:LowOccasionally:Production/manufacturing environmentFrequently:Lab environmentConstantly:Office environment
The targeted range for this role takes into account a range of factors that are considered when making compensation and hiring decisions; included but not limited to: skill sets; experience and training; licensure and certifications; and other business and organizational needs. The disclosed range estimate has not been adjusted for the applicable geographic differential associated with the location at which the position may be filled. Compensation decisions are dependent on the facts and circumstances of each case. The range provided is a reasonable estimate.
B. Braun offers an excellent benefits package, which includes healthcare, a 401(k) plan, and tuition reimbursement. To learn more about B. Braun and our safety healthcare products or view a listing of our employment opportunities, please visit us on the internet at .
Through its "Sharing Expertise " initiative, B. Braun promotes best practices for continuous improvement of healthcare products and services.
We are an equal opportunity employer. We evaluate applications without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, age, pregnancy, genetic information, disability, status as a protected veteran, or any other protected characteristic. Know Your Rights: Workplace Discrimination is Illegal, click here .
Compensation details: 5 Yearly Salary
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