Job Id: P1325227BOSJB_1677688400 Apply Now

The Position:

The QA Senior Associate is primarily responsible for quality oversight and guidance at 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 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.
• Monitor and report metrics and manage routine measurement.
• 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.
• Champion process improvement concepts.
• Evaluates the functional strengths and developmental areas in the Quality organization and focuses on continuous improvement.
• Support a state of continuous inspection readiness
• May work directly and build cross-functional relationships with Engineering, Facilities, Analytical Development and Regulatory.

Requirements:

• BS/MS in Biology discipline and 8+ 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.

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