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Supervisor Quality Assurance
Supervises a staff performing a wide range of 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. Position may be applicable to QC Analytical or Microbiological testing, Compliance, QCMIS, or Laboratory Operations. This position is responsible for results in terms of product quality and conformance to regulations and quality policies. In some instances, this position may be responsible for a functional area and may not have subordinates.
Job Function and Description
- Plans and schedules the work of QA analysts, QA technicians and inspectors. Ensures that all document control activities, inspection, and/or test procedures are properly completed and documented.
- Review all quality assessment results and determines whether to accept or reject manufactured products during the inspection process.
- Coordinates the timely 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 product lines and document control and retention schedule adherence.
- Work closely with Production Supervision, 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.
- Prepares daily reports and monthly summary on department specific performance indicators.
- Develops and maintains inspection documentation procedures, QA inspection instructions and department policy procedures. Ensures product compliance regulations are followed.
- Hires, trains and evaluates all personnel. Makes wage and salary recommendations and maintains performance records.
- Able to 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.
- Coordinates quarterly review meetings of quality data and trends to upper management.
- Coordinate customer complaint response and tracking as required.
Education and Experience Requirements
- Typically requires bachelor's degree in science, engineering or other related technical field. 5+ years of related experience.
- Some leadership experience preferred.
Key Skills, Abilities, and Competencies
- Working knowledge of statistics and production processes.
- Strong communication skills are needed to effectively supervise support personnel.
- Must have AS400 or PC knowledge.
Complexity and Problem Solving
- Able to follow directions.
- Able to identify when proper practices/ procedures are not performed.
- Follow SOPs and identify processes and results.
- Execute changes and corrections.
- Self-starting and task proficient.
- Escalate accordingly.
- Ensures timely communication of issues.
- Ensure appropriate communication between personnel, groups, and between departments.
- Coordinate activities, schedules staff, etc.
Internal and External Contacts
- Position acts as a support function to manufacturing operations and is required to routinely coordinate testing activities and communication of results with IG, Fractionation, and Albumin. In addition, the individual will also correspond with other support functions such as QA, Engineering, Maintenance, etc. Position may be required to participate in interdepartmental teams and communicate with different levels of personnel including management and site leadership.
Other Job Requirements
- In general, the position requires a combination of sedentary work, standing work, and walking around observing conditions in the facility.
- Will work around chemicals such as alcohol, acids, buffers and calcite that may require respiratory protection.
- May be required to work or be assigned to a different shift to meet business needs. Must be willing to work off shifts hours.
- Must be able to work supplemental hours as necessary to complete work commitments.
- May be required to work in a confined area.
- Primarily inside working conditions.
- Some clean room and cool/hot storage conditions.
Position may be allocated in QC Analytical, Microbiology, Compliance, QCMIS, and/or Laboratory Operations with general job requirements summarized below:
- Wet/dry chemistry or biochemistry test methods, compendial raw material testing, maintenance of associated assay equipment, and reconciliation of test results.
- Environment monitoring, critical utility sampling, endotoxin testing, bioburden for raw materials and in process, process samples, microbial identification and final product sterility testing.
- Manage and investigation of nonconformance events (OOL, OOS, etc.). Develop and deploy the site Contamination Control Master Plan (CCMP).
- Development, validation, and optimization of departmental assays.
- Support laboratory operations through sample control, equipment metrology, data reconciliation/ archiving, or computerized system programming and support.
Job posting excludes CO applicants
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.