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Quality Compliance Analyst II
| Company | Takeda |
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| Location | Thousand Oaks, CA, USA |
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| Salary | $27.6 – $43.37 |
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| Type | Full-Time |
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| Degrees | Bachelor’s |
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| Experience Level | Mid Level |
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Requirements
- Bachelor’s degree in science or engineering strongly preferred.
- Minimum 3 years’ industry experience.
- Experience with quality auditing or process improvement would be ideal.
- Functional knowledge of global cGMP regulations and quality systems requirements for pharmaceutical or biopharmaceutical operations.
- Good project management skills.
Responsibilities
- Support external regulatory inspections and local inspection readiness efforts and serve as a Quality Council Coordinator, Product Complaint Evaluator, and Gap Assessment Coordinator.
- Act as Lead Auditor for self-inspections and supplier audits.
- Coordinate efforts associated with GMP re-certification and product licensing.
- Lead or participate in efforts to mitigate facility compliance risks in GxP.
- Provide consultation, support, and guidance regarding GxP compliance concerns and serve as a plant resource for compliance to these requirements.
- Participate in local GMP walkthroughs and may present information during an inspection as a subject matter expert.
- Complete corrective actions on-time, support quality incidents and risk register.
- Participate or lead continuous improvement teams (e.g. DMAIC, Lean, Kaizen), improving quality and compliance.
- Actively champion and role model our Quality Culture of continuous improvement, learning organization principles and innovation.
- Complete Quality Systems responsibilities and other duties as assigned.
Preferred Qualifications
- Experience with quality auditing or process improvement would be ideal.
