Senior Quality Assurance Associate II
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Responsibilities:
- Primary interface with contract manufacturing organizations including oversight of ongoing CMO activities vs. Alkermes Quality policies and cGMPs. Oversight responsibilities include review of batch documentation, deviations, investigations, and change controls
- Facilitate and interact with QP for review and release process
- Maintenance and enhancement of quality systems to ensure conformance to Alkermes quality practices and international regulatory compliance requirements
- Represent department on cross site projects
- Monitor quality indicators highlighting trends and risks
- Independently lead and/or support investigations into variances and quality issues and able to assure that proper changes are made to guarantee continued and consistent product quality
- Proactively promote GMPs
- Provide quality assurance representation, guidance, leadership, and direction to product development teams for two or more different operations which include; API/drug substance, drug product and labeling/packaging operations
- Identify and evaluate quality, technical and product development issues
- Provide guidance/mentoring to QA Associates and cross functionally and provide performance feedback to CMO as appropriate
- Review of regulatory documentation and submissions
Skills / Qualifications
- 6+ years of experience in a pharmaceutical quality function
- Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing requirements
- QA Experience in pharmaceutical product development and expectations for early phase clinical trials
- Broad quality experience, preferably including manufacturing operations, API and drug product release, method development, method validation and transfer, QP release, process validation.
- Strong ability to troubleshoot and problem solve
- Demonstrated proficiency in use of risk assessment tools
- Ability to effectively plan, organize and prioritize work
Education
- Bachelor’s degree in a scientific discipline or related field
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