Senior Quality Assurance Associate III - External Commercial
Interface with contract manufacturing organizations including oversight of ongoing CMO activities vs. Alkermes Quality policies and cGMPs . Oversight responsibilities include review of batch documentation , analytical support, specifications, deviations, investigations, CoAs, etc. supporting product release
Support analytical GMP laboratory equipment and computer systems IQ/OQ/PQ, deviations, change controls and related procedural SOPs
QA lead on Analytical GMP systems support
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
Provide day to day operational QA expertise for product quality decisions particularly that relate to analytical oversight.
Lead Alkermes QA for CMOs on analytical results (release data and stability), for clinical and proprietary commercial products
Monitor quality indicators highlighting analytical trends and risks
Manage and 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 one and/or two different operations which include; API/drug substance, drug product (small and large molecule)
Identify and evaluate fundamental quality, technical and product development issues
Review of regulatory documentation and submissions for analytical support
Skills / Qualifications:
Five or more years of experience in the pharmaceutical quality function
Thorough knowledge of FDA and EU cGMPs and pharmaceutical manufacturing requirements, specifically analytical requirements
Thorough knowledge of GMP laboratory equipment and computer systems IQ/OQ/PQ requirements and data integrity needs
Experience in pharmaceutical product development
Broad quality experience, preferably including manufacturing operations, API and drug product specification, release, method development, method validation and transfer, stability, process validation.
Strong ability to troubleshoot and problem solve
Experienced in Quality Management Systems
Ability to effectively plan, organize and prioritize work
Alkermes, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, color, religion, sex, sexual orientation, gender expression and identity, national origin, ancestry, age, mental and physical disability, genetic information, any veteran status, military status or application for military service, or membership in any other category protected under applicable law.