Job Title: Analytical Quality Control Manager
Location: Thousand Oaks, CA
As the AQC Manager, you will plan, organize, supervisor, and monitor the daily operations, activities, and workflow for the laboratory personnel in the Analytical Quality Control (AQC) lab. Implement testing standards, policies and ensure safety measures are followed. This role will manage laboratory personnel with training, development, performance, and other areas as needed.
Manage the lab operations of your designated area of including oversight of day-to-day priorities, scheduling and activities.
Build a team, provide training, ongoing coaching, and performance management, including annual performance reviews. Support recruitment, development, and recognition of staff.
Support investigations into atypical results and troubleshooting of assays and instrumentation
Lead technical reviews, investigations, and process improvement projects.
Ensure timely completion of all testing, including special projects/protocols and ensure accuracy of laboratory documentation.
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.
Identify, implement, and oversee changes within quality systems.
Prepare, review and revise SOPs and specifications as required.
Write memos, reports, protocols, CPAs, and other appropriate documentation for proper functioning of the lab operation.
Assure equipment maintenance and calibration, and internal audits are performed on schedule.
Serve as a backup for various areas in AQC in Quality and Regulatory Inspections.
Lead in-plant audit ready status efforts for areas of responsibility.
Able to complete tasks with minimal direction from Head of AQC or Quality Leadership Team.
Able to prioritize multiple projects/workflows and manage time efficiently to meet timelines.
Support Laboratory Information management (LIMS) systems
Support current LIMS system
Support implementation of new LIMS system
May also perform other duties as assigned.
Advanced knowledge of basic laboratory functions, test methods, equipment (including but not limited to analytical equipment, autoclaves, incubators), processes and applicable procedures.
Thorough understanding of biological, biochemical and/or analytical chemistry methods, including raw materials.
Strong knowledge of FDA Regulations, Application of Good Laboratory Practices, Application of Good Manufacturing Practices and Application of Good Documentation Practices.
In-depth knowledge of operating and troubleshooting procedures for lab equipment, and quality and regulatory requirements pertinent to pharmaceutical and medical device manufacturing labs.
Proficiency with the MS Office suite of programs (including Microsoft Word, Excel, and PowerPoint)
Demonstrated decision-making skills, technical problem-solving ability, and analytical skills.
Strong leadership skills and demonstrated success in influencing a team.
Demonstrated ability to adapt in a constantly evolving environment.
Self – motivated with a strong sense of ownership in areas of responsibility.
Able to operate with agility and a learning mindset to drive continuous improvement.
Ability to work effectively, collaborate cross-functionally, and utilize resources efficiently
Advanced knowledge of change control practices for major equipment, critical systems, instrumentation, and computerized systems.
Experience in quality systems including exception management, change control, document control, deviation management, etc.
In-depth knowledge of how to implement investigation strategies and apply root cause failure analysis.
Able to write detailed investigation summary memos that consistently meet the requirements of the Takeda Quality Organization and the expectations of regulatory agencies.
Thorough knowledge of LIMS systems.
Knowledge and experience with change management, employee development and demonstrated strategic and critical thinking.
Experience in maintaining the budget for a department
Technical science degrees required (Chemistry or Biology preferred)
Bachelor’s Degree in the Sciences (or equivalent) with minimum of 5-7 years of related work experience OR
Master’s Degree in Sciences or MBA with 3-5 years of related work experience
Minimum 2-3 years of leadership experience.
Experience or Certified training in DMAIC and LEAN concepts preferred.
Comprehensive Healthcare: Medical, Dental, and Vision
Financial Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
Health & Wellness programs including onsite flu shots and health screenings
Generous time off for vacation and the option to purchase additional vacation days
Community Outreach Programs and company match of charitable contributions
Family Planning Support
Professional training and development opportunities
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.
Work in a cold, hot, wet environment.
Work around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
Office work/ laboratory environment
May support QC analysts in the laboratory as needed.
Must be able to work 5 days a week, 8 hours a day
May be required to more than a 40-hour work week.
May be required to be available after hours, weekends, holidays and/or on call as needed.
May be required to work or be assigned to a different shift/time as needed.
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.
This posting excludes Colorado applicants.
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.