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Job Title: QC Microbiology Supervisor
Location: Thousand Oaks, CA

About the role:

The QC Microbiology Supervisor is responsible for planning, organizing, and monitoring the daily operations, activities, and workflow for the laboratory personnel. Additionally, this role will implement testing standards, policies and ensure safety measures are followed. The supervisor will assist laboratory personnel with career development, performance and other areas as needed.

How you will contribute:

• Schedule, staff, train, and audit various activities for area of responsibility.
• Knowledge of quality systems including exception management, change control, document control, etc.
• Prepare, review and revise, as required, SOPs and specifications. Write memos, reports, protocols, CPAs, and other appropriate documentation for proper functioning of the lab operation.
• Able to write detailed investigation summary memos that consistently meet the requirements of the Quality Organization and the expectations of regulatory agencies.
• Knowledge of change control practices for major equipment, critical systems, instrumentation, and computerized systems.
• Serve as a backup for QC Manager in handling Quality and Regulatory Inspections.
• Assure equipment maintenance and calibration, and internal audits are performed on schedule.
• Knowledge of operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements pertinent to pharmaceutical and medical device manufacturing labs a plus.
• Able to lead, work effectively and efficiently in a team environment.
• 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.
• Develop and manage the performance/talent of direct reports.
• Provide general oversight, plan, organize, direct, and evaluate day to day laboratory tasks.
• Prioritize multiple projects/workflows and manage time efficiently to meet established timelines.
• Identify, implement, and oversee changes within quality systems.
• Lead technical reviews, investigations, and process improvement projects.
• May also perform other duties as assigned.
• Operate and troubleshoot procedures for lab equipment, and quality and regulatory requirements pertinent to pharmaceutical and combination drug manufacturing labs.
• Knowledge of laboratory safety including standard precautions and hazardous and biohazardous chemical handling.
• Complete tasks with minimal direction from Head of QC Microbiology.
• Knowledge of FDA regulations, application of Good Laboratory Practices, application of Good Manufacturing Practices and application of Good Documentation Practices.
• Assist in plant audit ready status efforts for assigned areas and participate in internal and external audits as SME for department and respond to audit observations.
• Participate in pro-active functions that impact production, increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support.
• Proficiency with the MS Office suite of programs (including Microsoft Word, Excel, and PowerPoint).
• Understand how to implement investigation strategies and apply root cause failure analysis.
• Ensure timely completion of all testing, including special projects/protocols and ensure accuracy of laboratory documentation.
• Strong leadership, organizational and time management skills.
• Assist 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.

What you bring to Takeda:

• Experience in laboratory, biotechnology, pharmaceutical or similar GMP manufacturing environment is strongly preferred.
• Documented/Certified training in DMAIC and LEAN concepts a plus.
• Minimum 1-3 years of related work experience; leadership experience is preferred.
• Bachelor’s Degree in Microbiology or Biological Sciences strongly preferred.

What Takeda can offer you:

• Health & Wellness programs including onsite flu shots and health screenings
• Family Planning Support
• Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
• Generous time off for vacation and the option to purchase additional vacation days
• Professional training and development opportunities
• Community Outreach Programs and company match of charitable contributions
• Comprehensive Healthcare: Medical, Dental, and Vision
• Tuition reimbursement

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 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.
• Able to work 4 days a week, 10 hours a day.
• Requires weekend and possibly holiday work.
• May require availability outside regular business hours and/or on call support as needed.
• Will need to remove all make-up, jewelry, contact lenses, nail polish and/or artificial fingernails while in the manufacturing environment.
• Laboratory and office 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.
• In general, it’s a combination of sedentary work, walking around the lab and supporting the daily activities as needed.
• May be required to work more than a 40-hour work week and/or be assigned to a different 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.

Base Salary Range: $79,800.00 to $114,000. Employees may also be eligible for Short-term and Long-Term Incentive benefits. Employees are eligible to participate in Medical, Dental, Vision, Life Insurance, 401(k), Charitable Contribution Match, Holidays, Personal Days and Vacation, Tuition Reimbursement Program and Paid Volunteer Time Off.

The final salary offered for this position may take into account many factors including location, skills, education, and experience

This posting excludes Colorado applicants.

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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.

Locations

USA - CA - Thousand Oaks - Rancho Conejo

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time