Quality Assurance Supervisor

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Job Description

The Los Angeles Fractionation Expansion (LAFE) QA Supervisor will be a member of the Los Angeles Teardown/Fractionation Building 5 Management team. LAFE QA Supervisor is responsible for all LAFE project activities related to Quality and manufacturing. This includes Risk Assessment, planning, documents development of manufacturing procedures (SOPs) and training curriculum for LAFE operation. You will also write /reviewing specification documents, writing SOPs ,PRs, C&Q documents, Scheduling Engineering, PPQ, CV, and production runs. LAFE supervisor will support building the LAFE quality and manufacturing team, manage the operation by supervising daily activities to ensure manufacturing goals and project deadlines are met by the commitment date while maintaining compliance with the current manufacturing practices (cGMPs), Environmental, Health, and Safety (EHS) guidelines and any other regulations that could apply.

Responsibilities

• Supervise ongoing daily departmental activities B5 Quality Operations

• Document creation/review/approvals.

• Perform Risk Assessments

• Write SOPs, and PR creation.

• Implement systems to maintain compliance with current good manufacturing practices (cGMPs), environmental health and safety (EHS) guidelines, FDA, and any other regulations that apply

• Ensure assigned projects and deliverables (i.e. corrective actions, exception reports, meeting action items) are completed per the commitment date.

• Ensure 100% compliance with established department procedures and regulations in producing high quality therapeutic products

• Will work and facilitate a team-oriented environment.

• Partner up with Manufacturing and Engineering for Quality on the Shop Floor collaboration to ensure sound Quality decisions are made with compliance to standards and procedures

• Responsible for adherence to specifications and procedures that have been established to ensure product Quality.

• Plan and schedule the work of Quality Associates

• Work with Manufacturing, Quality, Validation, Quality Control, and Engineering to ensure adequacy and appropriateness of inspection parameters, part specifications, and test methods for raw materials.

• Participate in regular meetings with Planning, Purchasing, Warehouse, Manufacturing, and customers to ensure clear communication and goal agreement.

• Partner with Manufacturing, Quality Control, Engineering, Supply Chain and Warehouse to ensure sound quality decisions are made with compliance to standards and procedures.

• Perform or oversee Raw Material Release Review, Deviation Lifecycle Management (i.e. Deviation, CAPA, Lab Investigation approval), Change Control, Gemba, and provide quality representation in meetings such as QWTs, tiered meetings, and other project related initiatives.

Qualifications

• Typically requires bachelors' degree in science, engineering or other related technical field. 3+ years of related experience. Experience in Quality with a pharmaceutical company or other similarly regulated industry.

• Have knowledge of biopharmaceutical/biotechnology manufacturing theories and processes.

• With ideas to improve and process simplification with breakthrough solutions.

• Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

• Knowledge of Pharmacopeia (USP, EP, etc.)

Physical Demands

• Must be able to lift, push, pull and carry up to 10 lbs.

• In general, the position requires a combination of sedentary work and standing or walking around observing conditions in the facility.

• Will work in controlled environments requiring special gowning. Will follow gowning requirements and wear protective clothing over the head, face, hands, feet and body.

• No make-up, jewelry, contact lenses, nail polish or artificial fingernails may be worn in the manufacturing environment.

• Will work in a cold and wet environment.

• Must be able to work multiple shifts, including weekends.

• Will work in construction area.

• May work in a confined area.

• Some Clean Room and cool/hot storage conditions.

• Must be able to work 100% onsite.

• May travel for business reasons, e.g. training and meetings. 15% travel.

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.

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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.

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