Compliance Investigator

Bio-Life Plasma, LLC

Thousand Oaks, CA

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Job Description

Job Title: Compliance Investigator
Location: Thousand Oaks, CA

About the role:

The Compliance Investigator conducts root cause investigations, closes deviations, supports assignment of proper corrective actions, and facilitates implementation for Manufacturing under the direction of Compliance Management.

How you will contribute:
  • Perform calculation, data collection in support of site, global CI initiatives, and management reviews.

  • Participate in the development and technical writing of documentation for the validation of equipment and required to support testing of the Thousand Oaks Manufacturing Facility.

  • Lead and/or drive completion of Lean or Six Sigma improvement projects and responsible milestones, as assigned.

  • Ensure that the daily operations of assigned functional area are met through scheduling, troubleshooting, and coaching.

  • Support and/or lead continuous improvement projects such as Yellow Belt, Green Belt, 5S, Kaizen, Just-do-it’s, VIPs using Lean/DMAIC concepts and philosophy.

  • Participate in the generation of test plans, protocols, and reporting documentation for the validation of equipment supporting testing of the Thousand Oaks Facility.

  • Perform review of test data with application of GDP.

  • Use Global LIMS or other computerized systems for trending test results.

  • May be required to conduct investigations and/or audits into Alert/OOL excursions.

  • Actively contribute to a team setting at the Thousand Oaks Manufacturing Facility and potentially with other work teams to increase efficiency, solve problems, generate cost savings, improve quality, and provide new product support, as needed.

  • Provide training and work direction for assigned functional areas.

  • Investigate deviations and write exception documents as required, using problem-solving tools as needed.

  • Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.

  • May be required to generate, execute, and/or summarize studies and/or review/revise of SOPs.

  • Complete and/or direct completion of special project/protocol testing in a timely manner.

  • Assist Compliance Supervisor in updating department metrics, reporting shift activities and leading daily operations to ensure coordination and efficiency.

  • Write and manage deviations (CAPA investigations, UIs, ICARs, OOXs, containment and/or corrective actions) under the direction of Compliance Management.

  • Lead and/or facilitate problem solving events. Lead the investigation closure of manufacturing compliance related documents. Use quality and statistical tools to identify and implement proper corrective and preventative actions to manufacturing non-compliance.

  • Represent the departments during the product release process, compliance, and Continuous Improvement projects and audits.

  • Participate in deviation related meetings and provide feedback, leadership, and support to manufacturing supervisors, trainers, and manufacturing technicians on the status of compliance of the department.

  • Conduct mediations to ensure timely release of product for customers. Assist in meeting product release time goals.

  • Emphasize training programs designed to enable staff to consistently execute all manufacturing processes with strict compliance to CGMPs and EHS regulations.

  • Identify and implement process improvement and Value Improvement Projects (VIP) to drive success in the areas of compliance, throughput, workplace safety, cost effectiveness, and product lead time.

  • Participate in regulatory and non-regulatory audits.

  • May perform other duties as assigned.

  • Ability to handle multiple tasks concurrently and complete tasks in a timely manner.

  • Effective organizational skills and ability to plan and suggest resolutions to technical problems.

  • Demonstrated working knowledge of assays/equipment in functional area.

  • Must be detail-oriented, conscientious, and responsible.

  • Capable of applying some decisions-making to problem-solve technical, compliance, or operational problems, as assigned.

  • Effective interpersonal communication. Must have effective verbal and written communication skills.

  • Can demonstrate the ability to guide people, encourage teamwork, and teach.

  • Working knowledge of applicable CTP/SOPs, EHS requirements, and application of CGMP/GDPs.

  • Good project management skills a plus.

  • Must be able to learn new computer systems and programs in a timely manner.

  • Demonstrate interpersonal skills with the ability to interface and influence with personnel of all levels and participate effectively and efficiently in a team environment.

  • In-depth process knowledge of related manufacturing equipment and processes.

  • Ability to analyze and interpret scientific and statistical data.

  • Experienced understanding of cGMP and other regulatory guidelines applicable to the medical/bio-tech industry.

  • Lead investigation and provide comprehensive investigation write up and/or presentations

  • Working knowledge of Quality Systems

  • Good computer skills and working experience with Microsoft Office applications.

What you bring to Takeda:
  • Bachelor’s degree preferred with 2-4 years of manufacturing experience.

What Takeda can offer you:
  • 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

  • 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:

  • The overall physical exertion of this position is sedentary work.

  • Must be able to perform gowning operations, including donning over garment and head cover.

  • May be required to balance and stand occasionally, when gowning and inside clean rooms.

  • 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.

  • Although assignments will be made specific to working hours, flexibility is expected, with the understanding that process validation and production objectives may necessitate changes in work hours, duties, and responsibilities.

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.

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