Document Control Specialist administers the approval, storage, and distribution of controlled documents using site document control systems. The specialist checks documents and reconciles errors or discrepancies.Disseminates knowledge to staff on document control processes and procedures. The Specialist ensures that approved documents are accessible, and that the quality system repository is updated and maintained.
Job Responsibilities:
The Document Control Specialist is responsible for day-to-day administration and oversight of the companys document control system.Responsibilities include processing document change requests, standard operation procedures (SOP), regulatory documents, forms, and key business process documents. The Document Control Specialist also maintains documents related to, but not limited to training verifications, corrective and preventative action (CAPA), non-conformances, quality investigations, customer complaints, batch records, recall notices, supplier and internal audits, supplier documents, and other internal and external correspondence.
Duties and Day-to-Day Responsibilities, but not limited to the following:
Overall control and maintenance of all documents and records.Prepare, distribute, and control documents in accordance with the document control procedures. Confers with document originators or other personnel to resolve discrepancies and compiles required changes to documents.Ensure SOPs are written in the required format and that document control and change request processes are followed.Expedite review, signature approval, and release of documents, as necessary.Generate and have knowledge in compiling necessary information for the following types of documents: MSDS, Allergen Statements, GMO Statements, Kosher/Halal Certificates, Origin Statements, Certificates of Origin, Nutritional Statements, Animal Origin Statements, Internal and External Specifications.Establish and maintain files and computerized files for active documents. Generate electronic/hard copy reports as needed. Process permanent, long term, short term, and vital records in all media forms.Assist in preparing draft manuals, drawings, and specifications.Responsible for distribution of finalized SOPs to the appropriate department(s).Establish and maintain a record of controlled documents on distribution.Assists in the coordination across departments and business units to revise an existing SOP or to create a new SOP.Monitors SOPs and other documents requiring revision and sends out notifications to other departments for the SOPs and documents requiring annual review.Assigns appropriate SOP number, work instruction number, Document Change Request (DCR) number, CAPA number, investigation number or other numbers for forms or documents, as necessary.Retrieves copies of all required documents shared in electronic hard drive and in hard copy format to satisfy regulatory requirements.Maintains and archives completed paper and electronic versions of documents. Arranges for disposal of documents.Other duties as assigned.Minimum Training, Education, and Experience Requirements:
High School Diploma required. Bachelors degree preferred.At least one year of related work experience in office work and documentation control; and/or an equivalent combination of work and education experience. Knowledge in use of spreadsheets, databases, word processing, and electronic inventory systems.Experience working with large volumes of documents.Proficient in Microsoft Office suite of applications including Word, Excel, PowerPoint, Outlook,and Visio.Work Environment:
Office and manufacturing environment.Sedentary physical activity requires reaching, sifting, lifting, finger dexterity, grasping, feeling, repetitive motions, talking and hearing.Visual requirements are for close vision, distance vision, peripheral vision, and ability to adjust focus.Over 50% of the time is spent looking directly at a computer.Occasionally required to stand and walk (or otherwise be mobile).Ability to deal with stressful situations as they arise.Ability to perform in a fast-paced operation that can run 24/7.Overtime and weekends may be required at times. Read LessJob Description:
Energetic baker for scratch baking (breads, rolls, laminated doughs, pastries) in a lab setting. Assist in the development and renovation of new and existing bakery products and bakery functional blends. Assist supervisors and project leaders in the research and development function in accordance with plans. Creates and maintains preliminary ingredient statements and nutrition facts panels. Some knowledge of FDA regulations and CFRs for regulated food products would be helpful. Utilizes laboratory and/or production equipment to perform tests and/or experiments on products. Evaluates and records all results. Conducts necessary literature searches and maintains up-to-date information on technology affecting assigned project areas. Maintain, investigates, develops and integrates assigned project areas, concentrating on bench top or production development.
Duties and Day-to-Day Responsibilities, but not limited to the following:
Development of prototypes for new product/concept exploration for evaluation.Conducts small batch (benchtop) experiments and produce sample products.Make recommendations for projects and experimental plans to support continuous improvements in dough systems and finished goods product quality.Develop standards of quality checks and evaluations for new and existing products/blends.Participates in sensory training and evaluation to help ensure the highest quality of our productsCoordinates and monitors the performance and evaluation of tests and experiments to ensure completion of new development projects within approved timeframe and standards.Exercises judgment in performing duties that are broadly defined. Solution to problems requires the application of established practices.Prepares, reviews and evaluates experimental plans and data. Determines project objectives and develops plans for timely completion Communicates and explains test procedures and results, project schedules and plans.Practices and comply with all Company policies and procedures (EEO, Harassment, Safety, Sarbanes Oxley, etc.)Performs other duties which are deemed by management to be an integral part of the job, including but not limited to fulfillment of work schedules, adherence to attendance policies, and other applicable operating rules, policies and procedures.Analyze the volume, texture and sensory properties of bakery products and organize evaluations with those responsible for research.Strong communication, problem solving and interpersonal skills are a must. Must have the math skills needed for formula and processing calculations. Eye for detail, diligently follow existing recipes and processes, and adhere to the highest standards of quality and consistency.Perform other related duties as assignedMinimum Training, Education and Experience Requirements:
High School Diploma, Baking School Diploma or technical degreeAbility to generate written and verbal communication as well as read and review correspondenceAbility to operate computer (Word, Excel, Power Point).Experience in bench top / scratch baking at a bakery.Experience in Bakery R&D (Bread, Enzyme and/or Dough Conditioner formulation experience strongly preferred).Experience designing and executing experiments.Ability to interpret data derived from experiments and react appropriately to the data.Knowledge of functional ingredients related to bakery science.Familiarity with ingredient suppliers.Physical Requirements:
Prolonged periods of standing.Ability to move to all areas of the plant, corporate and company-related facilities.Ability to lift 50 pounds. Ability to bend, squat, sit, stand, walk, and climb as needed to inspect or evaluate ingredients and/or equipment.Ability to safely and comfortably work in a production environment where noise and temperature may vary.Speech and hearing abilities that allow the individual to communicate clearly and distinctly in English (in person and via telephone) and/or another language if required.Ability to generate written and verbal communication as well as read and analyze correspondence.Work Environment:
Office, laboratory, and manufacturing environment.Ability to assist in a fast-paced operation that includes a dedicated group of quality-minded professionals.Ability to work 40 hours a week, overtime, and some Saturdays (if necessary 2-3 a year)Salary Range:
Dependent on experience Read LessMust be able to pass drug screen and phsycial and background check
Job Description:
The Quality Technician is responsible for supporting the quality of the operations within the manufacturing site. This includes providing quality support and inspection for incoming materials, product manufacture, and finished product shipping. The Quality Technician performs all job responsibilities following cGMP guidelines and practices.
Job Responsibilities:
The Quality Technician is responsible for the day to day quality oversight and routine inspection of the entire manufacturing operation from incoming raw materials, through product manufacturing, to finished product shipping. The individual works closely with production, warehouse, and operation personnel to assure shipping/receiving, production and sanitation activities meet the highest quality expectations under the supervision of Quality Assurance Manager.
Duties and Day-to-Day Responsibilities, but not limited to the following:
Minimum Training, Education, and Experience Requirements:
Associated Degree in a science related field; High School Diploma and a minimum of two years experience in quality role within a science-based environment; and/or an equivalent combination of education and experience.
Key Metrics:
The Quality Technician will be held accountable for the following metrics (not all inclusive) as it relates to the operational area assigned. Additional metrics may be assigned.
Behavior Competencies:
To perform the job successfully, the individual must demonstrate the following competencies:
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in-group problem solving situations; Uses reason even when dealing with emotional topics.
Technical Skills - Pursues training and development opportunities; Strives to continuously build knowledge and skills; Shares expertise with others.
Ethics - Treats people with respect; Keeps commitments; Inspires the trust of others; Works with integrity and ethically; Upholds organizational values.
Judgment - Displays willingness to make decisions; Exhibits sound and accurate judgment; Supports and explains reasoning for decisions; Includes appropriate people in decision-making process; Makes timely decisions.
Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Sets goals and objectives; Organizes or schedules other people and their tasks.
Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.
Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.
Quantity - Meets productivity standards; Completes work in timely manner; Strives to increase productivity; Works quickly.
Attendance/Punctuality - Is consistently at work and on time; Ensures work responsibilities are covered when absent; Arrives at meetings and appointments on time.
Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.
Initiative - Volunteers readily; Undertakes self-development activities; Seeks increased responsibilities; Looks for and takes advantage of opportunities; Asks for and offers help when needed.
Work Environment:
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job:
Job Description:
The laboratory technician is a trained, qualified individual that performs physical and chemical analysis of raw material and finished product samples received into the testing laboratory. The technician must perform all job-related duties in a safe, organized, and efficient manner to assure the site is compliant with regulatory requirements and customer expectations.
Job Responsibilities:
The Analytical Laboratory Technician is responsible for the accurate handling, preparation, and testing of raw material and finished good samples by following Lab Standard Operation Procedures (SOPs). The technician is responsible for reviewing the accuracy of testing results and initiating investigations when results do not conform to specifications under the guidance of their supervisor and other senior analysts.
Duties and Day-to-Day Responsibilities, but not limited to the following:
Receive and record samples upon arrival into the laboratory.Calibrate instruments as required and ensure the instrument works under proper conditions.Prepare reagents and standards on a scheduled basis.Follow daily testing schedule set by The Lab Supervisor to prioritize sample testing order.Perform sample preparation and analysis based on related SOPs.Inspect instrumentation routinely for potential issues/errors.Troubleshoot instruments/equipment with training.Troubleshoot potential testing issues, under the supervisors guidance.Analyze, record and review Quality Control samples and data.Document and record testing results accurately in lab notebooks and/or electronically where applicable.Maintain a clean work area, instrumentation and/or equipment.Complete Preventative Maintenance and troubleshooting records.Maintain testing records and retain samples.Other duties as requiredMinimum Training, Education and Experience Requirements:
One-year related experience and/or training in an analytical testing laboratory; orequivalent combination of education and experience.Knowledge of the basic principles and laboratory applications of chemistry, biology, and microbiology.Knowledge of current laboratory facilities, methods, equipment, materials, and ability to perform standardized chemical and microbiological examinations independently.Must be able to work in a collaborative environment as well as performing individual assignments.Ability to calculate figures and amounts such as proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry.Experience with testing vitamins and minerals using HPLC, ICP/AA, FTIR, GC, pH, Bulk Densities, Colorimeter is preferred but not required.Behavior Competencies:
To perform the job successfully, the individual must demonstrate the following competencies:
Problem Solving - Identifies and resolves problems in a timely manner; Gathers and analyzes information skillfully; Develops alternative solutions; Works well in group problem solving situations;Ability to present and interpret data for management and staff.Communication Skills- Possesses excellent written and oral communication skills; Speaks clearly and persuasively in positive or negative situations; Listens and gets clarification; Demonstrates group presentation skills; Participates in meetings; Writes clearly and informatively; Assures spelling and grammar are correct; Presents numerical data effectively; Able to read and interpret written information.Teamwork - Balances team and individual responsibilities; Exhibits objectivity and openness to others' views; Gives and welcomes feedback; Contributes to building a positive team spirit; Puts success of team above own interests; Able to build morale and group commitments to goals and objectives; Supports everyone's efforts to succeed.Planning/Organizing - Prioritizes and plans work activities; Uses time efficiently; Plans for additional resources; Sets goals and objectives; Able to manage multiple projects and initiatives on tight deadlines and delegate accordingly.Professionalism - Approaches others in a tactful manner; Reacts well under pressure; Treats others with respect and consideration regardless of their status or position; Accepts responsibility for own actions; Follows through on commitments.Quality - Demonstrates accuracy and thoroughness; Looks for ways to improve and promote quality; Applies feedback to improve performance; Monitors own work to ensure quality.Safety and Security - Observes safety and security procedures; Determines appropriate action beyond guidelines; Reports potentially unsafe conditions; Uses equipment and materials properly.Adaptability - Adapts to changes in the work environment; Manages competing demands; Changes approach or method to fit the situation; Able to deal with frequent change, delays, or unexpected events.Dependability - Follows instructions, responds to management direction; Takes responsibility for own actions; Keeps commitments; Commits to long hours of work when necessary to reach goals; Completes tasks on time or notifies appropriate person with an alternate plan.Key Metrics:
TheLab Technician/Analyst is held accountable but not limited to the following metrics as they relate to the operational area assigned.
AttendanceTeamworkRetests/ResamplesEfficiencyTime managementReduction in laboratory related testing errors.Perform other duties as assigned and directed.Work Environment:
The work environmental characteristics described here are representative of those an employee encounters while performing the essential functions of this job:
Office, laboratoryStanding for long periods of time.Ability to work in a fast-paced operation that can run 24/7.Exposure to chemical odors may be encountered. Hoods and personal protection equipment are available for use.Handling of hazardous chemicals including caustics, acids, and flammable hydrocarbons.Gloves, aprons, glasses and other P.P.E. are available and required when handling certain chemicals. Read Less