Senior Associate – Quality Assurance Finished Goods

Senior Associate – Quality Assurance Finished Goods

Requirements

• BS/MS or relevant/equivalent industry experience in scientific discipline preferred and 4-6 years of experience in a cGMP environment, with a focus on Lot Release, Product Disposition, Investigation/Deviation writing and reviewing
• Excellent organizational, interpersonal and communication skills
• Demonstrated proficiency and knowledge of cGMP (FDA and EU) and ICH requirements
• Experience in implementation and maintenance of quality systems
• Able to exercise judgment to determine appropriate corrective actions
• 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
• Excellent written & verbal communication skills
• Ability to travel domestically and internationally less than 10%

Responsibilities

• Review of batch records, testing data, and packaging/labeling from Contract Manufacturing Organizations (CMO) and Contract Testing Laboratories
• Perform lot disposition for finished goods (Commercial and Clinical)
• Track/maintain metric logs related to lot release and deviations/investigation
• Attend CMOs meetings as applicable to ensure resolution of batch record review comments or questions
• Represent QA on project teams as required
• Assisting in Investigation and deviation activities, and CAPAs, and providing general quality assurance support for the overall Quality System at Sarepta
• Scans approved documents to the QA files and provide applicable approval documentation to CMOs
• Assist with SOP writing and other QA activities as required
• Participate in external audit program as needed
• Actively participates as a member of the Quality Ops Team and partners with the technical and analytical team
• Perform data review, analysis, and identification of trends
• Apprise senior management of critical issues
• Support a state of continuous inspection readiness
• Work directly with Manufacturing, Engineering and Facilities on qualification and validation activities as applicable

Preferred Qualifications

• 4-6 years of experience in a cGMP environment, with a focus on Lot Release, Product Disposition, Investigation/Deviation writing and reviewing