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Job Description

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 to support site, global CI projects, 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 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 continuous improvement projects such as Yellow Belt, Green Belt, 5S, Kaizen, Just-do-it’s, VIPs using Lean/DMAIC concepts and philosophy.
Help produce 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 asked to conduct investigations and audits into Alert/OOL excursions.
Contribute to a team setting at the Thousand Oaks Manufacturing Facility and potentially with other work teams to increase efficiency, produce cost savings, improve quality, and provide new product support.
Investigate deviations and write exception documents.
Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, GLP, QSR, and cGMP regulations.
Will be asked to produce and implement studies and review/revise of SOPs
Complete and direct completion of special project/protocol testing.
Assist Compliance Supervisor in updating department reporting shift activities and leading daily operations to.
Write and manage deviations (CAPA investigations, UIs, ICARs, OOXs, containment and corrective actions) under the direction of Compliance Management.
Lead the investigation closure of manufacturing compliance related documents. Use quality and statistical tools to 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, and support to manufacturing supervisors, trainers, and manufacturing technicians on the status of compliance of the department.
Conduct mediations to ensure release of product for customers. Help meet product release time goals.
Emphasize training programs designed to promote staff to build all manufacturing processes with strict compliance to CGMPs and EHS regulations.
Implement process improvement and Value Improvement Projects (VIP) to achieve success in the areas of compliance, throughput, workplace safety, cost effectiveness, and product lead time.
Participate in regulatory and non-regulatory audits.
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.
Experienced understanding of cGMP and other regulatory guidelines applicable to the medical/bio-tech industry.
Lead investigation and provide comprehensive investigation write up and presentations
Working knowledge of Quality Systems.

What you bring to Takeda:

Bachelor’s degree preferred with 2+ 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 development opportunities
Tuition reimbursement

Important Considerations

At Takeda, our patients rely on us to provide 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. You may:

The physical exertion of this position is sedentary work.
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.
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 around chemicals such as alcohol, acids, buffers and Celite that may require respiratory protection.
Although assignments will be made specific to working hours with the understanding that process validation and production goals may necessitate changes in work hours and responsibilities.

More about us:

At Takeda, we are transforming patient care through the development of novel specialty pharmaceuticals and excellent patient support programs. Takeda is a patient-focused company to 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 provide 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

Research Compliance Specialist