Supervisor, Quality Assurance Lot Disposition

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Job Description

About the role:

As A Supervisor Quality Assurance Lot, you will manage and perform release of intermediate and final container product. Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines, and ensure all regulatory requirements for final container release are met according to the BLA. Create final container release process and tracking metrics, develop process flow for meeting release timelines, and develop reports for release reporting. Write APR (annual product review) reports for IGI and Albumin products. You will use of Electronic Batch Management (EBM) and will also provide guidance to other team members. Interacts frequently with functional superiors, peers, and provide training of your team. You will demonstrate effectiveness in task completion, empowerment of others, exception management, training, problem solving and team leadership. You will ensure batch reviews and deviations reviews are performed promptly to ensure on time release of batches.

How you will contribute:

• Must demonstrate and understanding of the manufacturing/Product Disposition processes and based on knowledge of regulations and regulatory trends.
• Work with Manufacturing, Manufacturing compliance, QC laboratories and Technical Services to ensure on time disposition of Final product.
• Manage product release process and release metrics
• Plan and schedules the work of QA Associates to ensure release timelines are met.
• Manage a staff of QA Associates to ensure all regulatory requirements related to final container release is met.
• Provide Training for the department
• Work with Production Management, Other QA Operations Groups, Quality Systems, Quality Labs and Engineering to ensure all release requirements are met promptly.
• Review electronic batch records, LIMS reports, identify nonconformance's and participate in investigation and Corrective and Prevention Action(CAPA) activities
• Write, review, revise, and approve written Standard Operating Procedures (SOPs) and submit procedural changes to meet Corporate, Divisional, Plant, Regulatory Requirements.
• Oversee audit of multiple reports (Protocols, Qualifications, Regulatory Submissions)
• Review Change Controls for impact to release process.
• Participate in QA multi-site projects in the role of contributor, coordinator or lead.
• Other responsibilities, tasks or projects as assigned.
• Must have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.

What you bring to Takeda:

• Bachelor's degree in Engineering, Science or related field or equivalent. Minimum of 4 years of QA experience in the life sciences and experience with a medical device / pharmaceutical or other similarly regulated industry.

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:

• May wear personal protective equipment (PPE) and other clean room garments daily. This may include safety shoes, safety glasses, aprons, face shields, lab coats, full body gowns, hair nets and gloves and hearing protection.
• Need to remove all make-up, jewelry, contact lenses, nail polish and artificial fingernails while in the manufacturing environment.
• Work in a cold, wet environment.
• Work multiple shifts, including weekends, or be asked to work supplemental hours.
• Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.

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

#LI-Onsite

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 employees may be eligible for short-term and/or long-termincentives. 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.

Locations

USA - GA - Social Circle - Hwy 278

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time