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Senior Quality Assurance Analyst
3 weeks ago
Job Title: Senior Quality Assurance Analyst
About the RoleWe are seeking a highly skilled Senior Quality Assurance Analyst to join our team. As a key member of our quality assurance department, you will be responsible for ensuring the quality and integrity of our products.
Key Responsibilities:
- Conduct quality testing to support product release, stability programs, and regulatory submissions.
- Support new product introductions and method transfers into the quality laboratory.
- Ensure testing complies with current Good Manufacturing Practices (cGMP), corporate quality standards, and regulatory requirements.
- Contribute to developing the lab as a center of excellence for analytical testing.
- Promote a culture of safety and quality with continuous improvement initiatives.
- Troubleshoot technical issues, analyze trends, and participate in root cause investigations.
- Collaborate with cross-functional teams including PDTS, Manufacturing Operations, and global quality teams to meet site and network objectives.
- Foster a culture of inclusion, ownership, and high performance.
Qualifications:
- A degree in Science, Quality, or a related technical discipline.
- 1-2 years of experience in biotechnology and/or the pharmaceutical industry.
- Solid knowledge of analytical testing and relevant regulatory guidelines (GMP, ICH, USP, global compendia).
- Proficiency in continuous improvement methodologies such as DMAIC, Lean, 5S.
About You
To be successful in this role, you should have a strong understanding of quality assurance principles and practices. You should also be able to work effectively in a team environment and communicate complex information to stakeholders.
Working Conditions
This is a full-time position that requires a high level of independence and self-motivation. You will be working in a dynamic environment with multiple priorities and deadlines.
How to Apply
If you are a motivated and detail-oriented individual who is passionate about quality assurance, please submit your application.