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Lead QA Technician
3 months ago
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Job Description
About the role:
Perform primary Quality Assurance tasks for Teardown/Fractionation (B5) or Purification (B8), overseeing daily Quality on the Shop Floor: review manufacturing batch records, conduct cGMP compliance walkthroughs, troubleshoot issues, support change control processes, and ensure adherence to FDA, ISO, and internal procedures. Identify and mitigate Quality and compliance risks, uphold Takeda's Quality Culture principles.
How you will contribute:
Partner with Manufacturing for Quality on the Shop Floor collaboration to ensure adherence to standards and procedures. Review and release batch records and associated documents based on assigned Standard Operating Procedures (SOPs). Conduct scheduled and unscheduled walkthroughs of Manufacturing and facilities to verify cGMP compliance and address any issues. Interpret and evaluate issues for conformity to standards and regulatory requirements; resolve non-conformances. Collaborate with manufacturing teams to enhance production efficiency, quality, and support new product initiatives. Investigate and review Deviations, CAPAs, and User Interventions as part of quality management. Identify areas for improvement to prevent recurring issues and drive continuous quality enhancement. Assist in ensuring accuracy and compliance of change packages and SOPs with regulatory requirements. What you bring to Takeda: Typically requires Bachelor's Degree in Science-Chemistry or Biological Science is preferred. 4+ years of 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. You may: Must be able to lift, push, pull and carry up to 25 lbs. In general, you will do a combination of sedentary work and walking around observing conditions in the facility. May work in a confined area. 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. Must be able to work multiple shifts, including weekends, as assigned. Must be able to work overtime as required. 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. #GMSGQ #ZR1 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 - CA - Los AngelesU.S. Hourly Wage Range:$ $42.31 The estimated hourly wage range reflects an anticipated range for this position. The actual hourly wage 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 hourly wage offered will be in accordance with state or local minimum wage requirements for the job location. U.S. based employees may be eligible for short-term incentives. 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. 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 StatementTakeda 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.Locations USA - CA - Los Angeles Worker Type Employee Worker Sub-Type Regular Time Type Full time