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Quality Assurance Specialist
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Sterility Assurance Specialist I
2 months ago
We are seeking a highly skilled Sterility Assurance Specialist I to join our team at WuXi AppTec. The successful candidate will be responsible for ensuring the quality and integrity of our products by implementing and maintaining sterility assurance programs.
Key Responsibilities- Develop and implement environmental monitoring performance qualification (EMPQ) and aseptic process validation (APV) protocols.
- Own change control tasks associated with qualification or program revisions.
- Author risk assessments in support of microbial control strategy and sterility assurance programs.
- Provide aseptic processing training for manufacturing and support personnel.
- Participate in continuous improvement and implement best practices to ensure compliance with sterility assurance regulations and guidelines.
- Perform regular GEMBA-style assessments of the aseptic process to identify deficiencies and provide real-time coaching to aseptic staff.
- Author new and revised procedures for the Sterility Assurance department.
- Data approval in EMDS system.
- Coordinate with project teams in design, setup, and execution of projects.
- Maintain current regulatory knowledge and stay up-to-date with best practices.
- Participate in business excellence projects within SA and across the site.
- Bachelor's degree with a major in Biology, Microbiology, or related Life Science.
- 3-5 years of relevant technical experience.
- Knowledge of GLP and cGMP guidelines.
- Ability to make decisions based on a wide knowledge of factors.
- Ability to evaluate technical data and write technical documents.
- Ability to work under limited supervision and handle problems of a difficult nature.
- Ability to accurately and reproducibly perform arithmetic calculations.
- Ability to record data accurately and legibly.
- Ability to understand and follow verbal or demonstrated instructions.
- Proficient in Oral & Written communication skills.
- Need to be able to read, write, and understand English.
- Proficient in Microsoft (Excel, Word, Outlook).
We value integrity, dedication, working together, and sharing success. We believe in doing the right thing and doing it right. Our greatest asset is our people, and we are dedicated to providing opportunities for internal growth with direct access to a dedicated and accessible Human Resources team.
