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Job Description About the role: As a Supervisor, Quality Control, you will have a staff performing many biological, chemical, or physical analyses on pharmaceutical products (biologics and drugs) through all stages of the manufacturing process from incoming raw materials to finished goods and may include environmental monitoring programs. You may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations. You will be responsible for results regarding product quality and conformance to regulations and quality policies. In some instances, you will be responsible for a functional area and may not have subordinates.
How you will contribute:
- Plans and schedules the work of QA analysts, QA technicians and inspectors.
- Ensure that all document control activities, inspection, and test procedures are completed and documented.
- Review all quality assessment results and determine whether to accept or reject manufactured products during the inspection process.
- Coordinate the release of licensed products, intermediate and clinical/IND lots, and Packaging, according to schedule.
- Track performance indicators such as average number of defects per million units inspected as a process average for all products and document control and retention schedule adherence.
- Work with Production Management, Quality, and Engineering to ensure adequacy and appropriateness of inspection parameters, product specifications, test methods, and other controlled documentation.
- Evaluate new raw materials to develop first of code criteria for raw material testing.
- Prepare daily reports and monthly summary on department specific performance indicators.
- Maintain inspection documentation procedures, QA inspection instructions and department policy procedures. Ensure product compliance regulations are followed.
- Hire, trains and evaluates all personnel.
- Navigate, answer alerts and review Batch Records in EBM.
- Provide necessary floor support to the manufacturing teams and help in resolving compliance concerns.
- Responsible for change control activities/documentation. Required to perform review of submission documents applicable to the product of the department.
- Coordinate quarterly review meetings of quality data and trends to upper management.
- Coordinate customer complaint response and tracking.
- Working knowledge of statistics and production processes.
- Must have AS400 or PC knowledge.
- Identify when proper practices/ procedures are not performed.
- Follow SOPs and identify processes and results.
- Implement changes and corrections.
- Escalate accordingly.
- Ensure communication of issues.
- Ensure communication between personnel, groups, and between departments.
- Coordinate activities, schedules staff.
What you bring to Takeda:
- Requires Bachelor's degree in science, engineering or other related technical field. 5+ years of related experience.
Important Considerations At Takeda, our patients rely on us to deliver quality products. As a result, we must follow strict rules in our manufacturing facilities to ensure we are not endangering the quality of the product. In this role, you may:
- In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.
- May work in a confined area.
- Inside working conditions.
- Some clean room and cool/hot storage conditions.
- May work in a controlled environment requiring special gowning and wear protective clothing over the head, face, hands, feet and body. This may include additional hearing protection for loud areas.
- Will need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
- May work in a cold, hot or wet environment.
- May work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
- May work or be assigned to a different shift to meet needs. Must be willing to work off shift's hours.
- Will work supplemental hours to complete work commitments.
More about us: At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and best in class patient support programs. Takeda is a patient-focused company that will inspire and empower you to grow through life-changing work.
Certified as a Global Top Employer, Takeda offers stimulating careers, encourages innovation, and strives for excellence in everything we do. We foster an inclusive, collaborative workplace, in which our teams are united by an unwavering commitment to deliver Better Health and a Brighter Future to people around the world.
Takeda Compensation and Benefits Summary We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices.
For Location:USA - GA - Social Circle - Hwy 278
U.S. Base Salary Range: $84,000.00 - $132,000.00
The estimated salary range reflects an anticipated range for this position. The actual base salary offered may depend on a variety of factors, including the qualifications of the individual applicant for the position, years of relevant experience, specific and unique skills, level of education attained , certifications or other professional licenses held, and the location in which the applicant lives and/or from which they will be performing the job. The actual base salary offered will be in accordance with state or local minimum wage requirements for the job location.
U.S. based e mployee s may be eligible for s hort - t erm and/ or l ong- t erm incentive s . U.S. based employees may be eligible to participate in medical, dental, vision insurance, a 401(k) plan and company match, short-term and long-term disability coverage, basic life insurance, a tuition reimbursement program, paid volunteer time off, company holidays, and well-being benefits, among others. U.S. based employees are also eligible to receive, per calendar year, up to 80 hours of sick time, and new hires are eligible to accrue up to 120 hours of paid vacation.
EEO Statement Takeda is proud in its commitment to creating a diverse workforce and providing equal employment opportunities to all employees and applicants for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, parental status, national origin, age, disability, citizenship status, genetic information or characteristics, marital status, status as a Vietnam era veteran, special disabled veteran, or other protected veteran in accordance with applicable federal, state and local laws, and any other characteristic protected by law.
LocationsUSA - GA - Social Circle - Hwy 278
Worker TypeEmployee
Worker Sub-TypeRegular
Time TypeFull time
