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Quality Assurance Manager

  • Anywhere

Company :
Affinity Executive Search

Location :
Cleveland, Ohio

Expiry Date :
Mon, 05 Jul 2021 23:59:59 GMT

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Description :
Contract research and manufacturing company in suburban Cleveland is searching for a Quality Assurance Manager provide quality oversight and support to the sites technical operations group for the manufacture and characterization of non-clinical, clinical and commercial products in compliance with GMP and GLP guidelines.

Requirements for QA Manager:

* Bachelors degree in a technical or scientific discipline
* 7+ years experience in the pharmaceutical / biotech industry
* 5+ years experience in Quality Assurance supporting manufacturing and characterization of small molecule drug substance for clinical and commercial use in a contract environment.
* Working knowledge and technical understanding of the manufacture and testing of small molecule drug substance and drug product
* Knowledge of GMP and GLP principles with respect to FDA and EMA regulations and guidelines
* Knowledge of drug development process
* Experience in deviation investigations, root cause analysis, risk assessment and developing corrective action plans
* Experience in data integrity / 21CFR Part 11 Compliance
* Experience is process validation, analytical method validation and equipment qualification
* Excellent communication and documentation skills
* Experience managing multiple priorities and quality assurance staff