SUMMARY
Perform one or more of the following duties and responsibilities in support of Quality Assurance program under minimal supervision.
FUNCTIONS
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Request Quality on incident triage team.
- Approve Environmental Characterization reports.
- Release of sanitary utility systems.
- Approve planned incidents.
- Represent QA on NPI team.
- Lead investigations.
- Lead site audits.
- Own site quality program procedures.
- Designee for QA manager on local CCRB.
- Review Risk Assessments.
- Support Automation activities.
- Support facilities and environmental programs.
- Review and approve Work Orders.
- Review and approve EMS/BMS alarms.
- Approve NC investigations and CAPA records.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
EDUCATION
-Doctorate OR
-Masters + 2 years of directly related experience OR
-Bachelors + 4 years of directly related experience OR
-Associates + 8 years of directly related experience OR
-High school/GED + 10 years of directly related experience.
COMPETENCIES/SKILLS
- Project management skills.
- Strong organizational skills, including ability to follow assignments through to completion.
- Initiate and lead cross functional teams.
- Enhanced skills in leading, influencing and negotiating.
- Strong knowledge in area of expertise.
- Collaborate and coordinate with higher level outside resources.
- Strong knowledge of and experience with processes involved in manufacturing and distribution, QA, QAL, validation and process development.
- Demonstrate ability to interact with regulatory agencies.
- Strong word processing, presentation, database and spreadsheet application skills.
- Strong communication (both written and oral), facilitation and presentation skills.
- Strong skill in working independently and to effectively interact with various levels.
- Advanced data trending and evaluation.
- Ability to evaluate compliance issues.
- Demonstrate the Values/Leadership Practices.
Preferred: Microbiology, Biology or Life Sciences
What attributes (i.e. - preferred qualifications) would make this candidate stand out?
Knowledge in:
• Environmental Monitoring, Microbial Identification (Micro ID), Critical Utilities (CU) monitoring
• Sampling monitoring: equipment and techniques
• Data trending and evaluation
• Microbiological testing methods and standards for clean rooms and controlled environments
• Aseptic behavior in manufacturing areas to prevent contamination
• Facility cleaning and disinfection
• Familiarity with the regulatory requirements and quality standards for environmental monitoring in the pharmaceutical industry: Annex 1, FDA Guidance, ISO-14644-1, USP
• Word processing, presentation, database, and spreadsheet application skills (Smartsheets, Microsoft Office: word, power point, and excel)
• Ability to use software tools and statistical techniques to visualize, interpret, and report on environmental/CU monitoring data
• Ability to analyze trend reports and environmental/CU data to identify areas for improvement
• Hands on experience in electronic systems for instance: Documentation platforms such as Veeva, Spotfire, LIMS, Maximo.
• Use of artificial intelligence tools such as data analytics and large language models
• Strong communication (both written and oral), facilitation and presentation skills. Fully Bilingual in English and Spanish.
Specific responsibilities include but are not limited to:
• Supports the AML site GMP buildings Environmental Monitoring Process.
• Generates Environmental Monitoring and Critical Utilities trend reports.
• Participates and or Leads Risk Assessments to evaluate sampling sites for routine monitoring of GMP areas.
• Provides assessments to change control records, deviations, audit processes that need support form the Environmental Control perspective.
• Participate in forums such as the Environmental Control Network, Aseptic Council and or Contamination Control Network as assigned.
• Attends AML GMP Buildings Quality system forums and or Management Review meetings to present environmental and critical utilities data and recommend actions based on the data evaluation.
• Ensures that facilities, equipment, materials, organization, processes, procedures, and products comply with cGMP practices and other applicable regulations.
• Supports Continuous Improvement initiatives, programs, and projects.
• Collaborates cross functionally as needed to ensure the Quality Management System processes are performed in alignment with established procedures.
• Alerts senior management of quality, compliance, supply, and safety risks.
• Supports internal/external audits and inspections as needed.
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JOB TITLE: Maintenance Technician
JOB LOCATION: Hebron, KY (Onsite Position)
Contract Duration: 05 months
Day shift 6:30am-4pm
JOB DESCRIPTION:
Responsibilities include the safety and maintenance of building infrastructure or manufacturing/production equipment and systems.May be responsible for the repair, maintenance, installation and enhancement of machinery and mechanical equipment.Mechanical responsibilities may apply to equipment, machinery, electrical, plumbing, and / or HVAC.May manage coordination and modification of building space - space design standards, allocation, modifications, moves and expansion.May conduct facility inspections and/or equipment condition assessments to determine necessary modifications, including repair work and replacements / capital improvements.Responsibilities include predictive, preventive and proactive maintenance analysis as well as designing and implementing long-term continuous improvement applications and systems to enhance facility and/or production reliability and infrastructure specific elements of quality system compliance.Documents and reports issues to provide and safe and reliable environment.Technical roles with responsibility for electrical, mechanical, plumbing, and production/manufacturing equipment technicians as well as tool makers and machine setters should be assigned to this job family.
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Shift: Monday to Thursday 8:00 pm to 6:30 am/ OT as needed on Friday 8:00 pm to 6:30 am
Industrial Maintenance experience required. NO building/ facilities or auto mechanic maintenance
Responsible for maintaining, troubleshooting, and improving industrial manufacturing equipment to ensure safe, reliable, and efficient operations. The role requires strong electrical, controls, and PLC expertise, with a focus on proactive maintenance programs that increase machine uptime and minimize downtime. This individual will also serve as a mentor to junior technicians while working collaboratively across the organization to support production, safety, and continuous improvement goals.
POSITION DESCRIPTION:
· Performs all duties (repair, corrective, projects, and PM’s) in an urgent, but safe manner.
· Develops and recommends changes to proactive programs to increase machine uptime.
· Ability to install, maintain, and troubleshoot power distribution systems, branch circuits, lighting systems, transformers, and wiring methods and materials
· Ability to install, maintain, and troubleshoot relay logic, ladder diagrams, control components-- photo eyes, motor starters, relays, limit switches, proximity sensors, timers, solenoids, Servo drives, frequency inverters, linear drives, tachs, and encoders
· PLC programs, ability to troubleshoot ladder logic (read use for troubleshooting), components (CPU back planes, I/O boards, counters, modules, and devices) and communications modules (Ethernet)
· Mentors junior technicians by motivating, providing guidance and directions to help them achieve their goals
· Develops and maintains a good working relationship across all levels in the organization
· Strong demonstrated ability with understanding electrical schematics, control logic, volt and ohm meter use.
· Completes all safety training as assigned by the Company and complies with all safety programs, policies and procedures.
· Perform additional duties/assignments that may be required by management from time to time.
· Ability to work all days and shifts, including overtime (10 hours a day, 4 days a week operation, including holidays). Friday overtime is frequently scheduled.
· Other duties as assigned by team lead and/or manager.
REQUIREMENTS:
· High school diploma or equivalent.
· Two-year Technical Mechatronics degree preferred.
· Six years’ experience in an industrial manufacturing environment as a maintenance technician.
Read LessTitle: Associate Technician Production Operations I (O1)
Contract duration: 05 months
Location: Carlsbad, CA
Key Responsibilities:
Read, comprehend and follow established work instructions and procedures with emphasis on quality, Execute the daily production plan to due date conformance and quality standards, Train to Standard Operating Procedures (SOPs).
Follow engineering drawings, work order information, SOPs, and other written and verbal specifications in the manufacturing process while maintaining FDA requirements, Independently execute work regarding formulating, filling, testing and packaging, Apply basic analytical skills or scientific methods to perform daily tasks, Perform the set-up, calibration, testing and troubleshooting of reagent components and instruments, Conduct testing on solutions which include pH, conductivity, and density, to ensure adherence to production/process specifications, Assure compliance with FDA Quality System Regulations (QSR), Good Manufacturing Practices (GMP), and ISO regulatory requirements, Work directly and cooperatively with cross-functional team members to troubleshoot issues and ensure emphasis on quality, Identify, recommend and implement quality improvements including but not limited to production methods, equipment performance, product quality and efficiencies, Learn and participate in the company's lean manufacturing principles, Maintain a safe and clean working environment by complying with procedures, rules, and regulations, Perform other duties and cross training as assigned, Train new team members on equipment operations and work procedures as needed, Ability to complete appropriate paperwork, maintain accurate records of production and report status of work. Must read, write and speak fluent English.
Proficiency with Microsoft applications.
Our Leadership Competencies:
We value associates with solid decision making and priority setting skills, and who are going to thrive in a diverse environment where individual contribution and team effort are equally important.
PHYSICAL DEMANDS:
While performing the duties of this job, the associate is regularly required to stand for prolonged period of time. The employee is frequently required to talk and hear; use hands to handle or feel; and reach with hands and arms above shoulder height and below the waist. The associate must be able to read and speak English. Using proper lifting techniques, the employee must be able to lift up to 30 lbs. Associate must have good hand dexterity. Ability to maneuvers assembly components by hand in a repetitive manner conducive to efficiency, job specifications, safety, and quality goals. Ability to frequently stand (80%), bend, kneel, lift and sit to accomplish assembly production goals. EDUCATION/EXPERIENCE: Must have 2+ years relevant experience. Experience in a regulated industry preferred (e.g. FDA, ISO).
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