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Quality Control Manager
2 months ago
About the Role:
We are seeking a highly skilled and experienced Quality Control Manager to join our team at Takeda Pharmaceutical. As a key member of our quality assurance team, you will be responsible for ensuring the quality and integrity of our pharmaceutical products.
Key Responsibilities:
- Plan and schedule the work of quality assurance analysts and technicians.
- Ensure that all document control activities, inspections, and test procedures are completed and documented.
- Review 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 summaries on department-specific performance indicators.
- Maintain inspection documentation procedures, QA inspection instructions, and department policy procedures.
- Ensure product compliance regulations are followed.
- Hire, train, and evaluate 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.
Requirements:
- Requires Bachelor's degree in science, engineering, or other related technical field.
- 5+ years of related experience.
Working Conditions:
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 hours. Will work supplemental hours to complete work commitments.
