Associate Manager, Analytical Quality Assurance Specialist
4 weeks ago
As the Associate Manager, Analytical Quality Assurance, you will be responsible for ensuring the quality and compliance of analytical data in the laboratory. This includes reviewing and approving certificates of analysis, managing the analytical data review team, and ensuring that all laboratory procedures and protocols are followed.
Key Responsibilities- Review and approve certificates of analysis for raw materials, packaging materials, in-process, finished product, stability, and hold time study samples.
- Manage the analytical data review team and assign job duties according to priorities.
- Ensure that all laboratory procedures and protocols are followed, including good documentation practices and ALCOA+.
- Support annual product review for analytical data and prepare/commercial certificate of analysis.
- Ensure that the principle of good documentation practices and ALCOA+ are met in the laboratory.
- Review data to comply with laboratory procedures, test methods, protocols, GLP, GDP, and cGMP, and work with laboratory personnel for any corrections.
- Knowledge of 21 CFR, ICH, USP, and other applicable regulatory requirements and standards.
- Ability to maintain integrity and honesty at all times.
- Ability to communicate and lead with transparency.
- Lead department for optimal performance and set course for future improvements.
- Accountable for performance and results of department.
Requirements include a minimum of a BA/BS in Pharmacy, Biochemistry, Chemistry, or related field with 5+ years of experience in the biotech or pharmaceutical industry. Management experience in Quality Control is required, and an MS/MA is preferable.
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