- and implementing a quality system to support bioanalytical lab operations.
- as a company SME on GLP requirements from a quality assurance perspective.
- and reporting inspections, data audits, quality systems audits, etc.
- review, and authorize documents necessary to maintain GLP compliance.
- with management to stay informed about compliance challenges and communicate audit findings, facilitating necessary discussions.
- the controlled document system to ensure accurate and up-to-date documentation.
- the quality aspects of sponsor visits and audits.
- 3+ years working in a GLP environment with at least 2+ years in a QA function
- familiarity with quality assurance systems in a bioanalytical lab – experience with ICH M10 guidelines for bioanalytical method validations
- understanding of regulatory requirements and quality standards applicable to pharmaceutical manufacturing (e.g., FDA regulations, GLP guidelines)
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Quality Assurance Manager - North Carolina, United States - EPM Scientific
Description
Quality Assurance Manager - GLP Bioanalytical Lab
Company Summary: An international CRO, specializing in small molecules and large molecule bioanalysis, is currently seeking a driven, motivated, and multi-faceted QA Manager. The QA Manager will play a critical role in ensuring lab operations are in compliance with GLP requirements. The ideal candidate will have strong leadership skills, attention to detail, and a thorough understanding of GLP requirements.
The QA Manager will be responsible for:
The QA Manager should have the following qualifications:
If you see yourself in this QA Manager role and are interested, then please don't wait to apply.
