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Senior Associate, QC Data Reviewer

Company: Sarepta Therapeutics Inc.
Location: Andover
Posted on: February 12, 2024

Job Description:

The QA Senior Associate is primarily responsible for quality oversight and guidance at Sarepta's in-house testing facilities. The Senior Associate will be a key member of QA team and perform QA review of executed Quality Control assay documentation, laboratory walkthroughs, and provide guidance to ensure adherence to Sarepta's quality policies, practices, procedures standards and cGXP compliance to US, ATMP and EU regulations.Primary Responsibilities Include:* Actively participates as a member of the Quality Ops Team and partners with the Quality Control and analytical team in review of executed laboratory testing documentation.* Support Testing Operations during batch production and disposition, ensuring unexpected events are handled compliantly and in a timely manner.* Revise, review, and approve documents including testing documentation in support of product disposition and stability as well as standard operating procedures.* Perform data review, analysis, identification of trends, and complex problem solving.* Assist with problems of diverse scope using a high degree of judgment and risk-based decision making* Apprise senior management of critical issues.* Support a state of continuous inspection readiness* May work directly and build cross-functional relationships with Engineering, Facilities, Analytical Development and Regulatory.Desired Education and Skills:* BS/MS in Biology discipline and 4+ years of experience in a cGMP environment, with strong knowledge of FDA, EU, ATMP and JP regulations. Experience in setting up GMP operations and systems in new facility is beneficial.* Detail oriented and the ability to communicate effectively, proactively, and professionally to clients and members of the management team.* Skilled in use of Microsoft Outlook, PowerPoint, Word, Excel and GMP system programs and spreadsheets is mandatory, as is a capacity to follow written procedures, and the ability to read, write, speak, understand and to be understood in English.#LI-HybridThis position is hybrid, you will be expected to work on site at one of Sarepta's facilities in the United States and/or attend Company-sponsored in-person events from time to time.The targeted salary range for this position is $88,000 - $110,000 per year. Sarepta is making a good faith effort to be transparent and accurate around our hiring ranges. The salary offer is commensurate with Sarepta's compensation philosophy and considers factors including, but not limited to, education, training, experience, external market conditions, criticality of role, and internal equity.Candidates must be authorized to work in the U.S.Sarepta Therapeutics offers a competitive compensation and benefit package.Sarepta Therapeutics is an Equal Opportunity/Affirmative Action employer and participates in e-Verify.

Keywords: Sarepta Therapeutics Inc., Boston , Senior Associate, QC Data Reviewer, Other , Andover, Massachusetts

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