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Job Description

Job Title: Quality Control Supervisor

Location: Thousand Oaks, CA

About the role:

The QC Supervisor is responsible for shaping, and monitoring daily operations, activities, and workflow for the team. You will ensure the implementation of testing standards, policies and ensures safety measures are followed. Additionally, the supervisor supports laboratory personnel with performance, development, feedback and other areas.

How you will contribute:

• Provide general oversight by planning, organizing daily laboratory tasks.
• Manage the daily production, scheduling, staffing, material management, compliance, training, and auditing activities.
• Coach and provide feedback to lead personal and team performance.
• Ensure completion of all testing, including special projects/protocols and ensure accuracy of laboratory documentation.
• Help with the implementation and interpretation of applicable quality and regulatory requirements (e.g., FDA, GLP, QSR, cGMP, USP, and CDR rules, and guidelines), and ensure compliance with testing SOPs and specifications.
• Operate and troubleshoot procedures for lab equipment, and quality and regulatory requirements relevant to pharmaceutical and combination drug manufacturing labs.
• Help with plant audit ready status efforts for assigned areas and participate in internal and external audits as SME for department and respond to audit observations.
• Lead technical reviews, investigations, and process improvement projects.
• Identify, and oversee changes within quality systems.
• Support review of Global documents to ensure local compliance and evaluate gaps within the QC department.
• Assure equipment maintenance and calibration, and internal audits are performed.
• Prepare ,, SOPs and specifications. Write memos, reports, protocols, CPAs, and other appropriate documentation for proper functioning of the lab operation.
• Participate in proactive functions that impact production, increase efficiency, solve problems, create cost savings, improve quality, and provide new product support.
• Individual with demonstrated ability to be a team leader and team player.
• Knowledge of basic laboratory functions, test methods, equipment (including but not limited to analytical equipment, autoclaves, incubators, and environmental monitoring equipment), processes and applicable procedures.
• Knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices.
• Knowledge of laboratory safety including standard precautions and hazardous and biohazardous chemical handling.
• Experience with programs (including, Excel, and PowerPoint).
• Knowledge of change control practices for major equipment, critical systems, instrumentation, and computerized systems.
• Knowledge of quality systems including exception management, change control, document control, etc.
• Knowledge of operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements important to pharmaceutical and medical device manufacturing labs.
• Write detailed investigation summary memos that meet the requirements of the Quality Organization and the expectations of regulatory agencies.
• Understand how to implement investigation strategies and apply cause failure analysis.

What you bring to Takeda:

• Bachelor's degree in Biological Sciences of microbiology strongly preferred.
• Minimum 3 years of related work experience; leadership experience is preferred.
• Experience in laboratory, biotechnology, pharmaceutical or similar GMP manufacturing environment is strongly preferred.
• Documented/Certified training in DMAIC and LEAN concepts a plus.

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:

• In general, it's a combination of sedentary work, walking around the lab and supporting the daily activities as needed.
• 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/or 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.
• Able to work 4 days a week, 10 hours a day including weekends and possibly holidays.
• May require availability outside regular business hours and/or on-call support.
• Able to work more than a 40-hour work week and adjust shift as needed.

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.

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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 - Thousand Oaks - Rancho Conejo

U.S. Base Salary Range:

$84,000.00 - $132,000.00

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 - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time