What are the responsibilities and job description for the Associate I, DS QA Operations position at Sarepta Therapeutics?
The QA Associate is responsible for batch record review and disposition of clinical and commercial lots. The Senior Associate will be a key member of QA team in the assessment of CMO batch compliance with FDA and ICH regulations as well as internal procedures. This person will also be responsible for deviation and investigation review and closure and data entry. In addition, there will be periodic tasks such as SOP and policy revisioning as part of continuous improvement initiatives.
Primary Responsibilities Include
The targeted salary range for this position is $60,000 - $75,000 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.
Primary Responsibilities Include
- Actively participates as a member of the Quality Assurance Ops Team and partners with the technical and analytical team.
- Support Manufacturing and Testing Operations during CMO batch production, ensuring unexpected events are handled compliantly and in a timely manner.
- Review and approve documents including: CMO Manufacturing batch records, lot disposition documentation/systems, Certificates of Analysis, deviations, investigations and OOS in support of product release.
- Data entry of lot release cycle times for metrics generation
- Assist with problems of diverse scope using a high degree of judgement and risk-based decision making.
- Apprise management of critical issues.
- Support a state of continuous inspection readiness.
- BA/BS degree in a related field, 1-2 years related experience OR AA/AS degree in a related field, 3 years related experience in a cGMP environment, with strong knowledge of FDA, EU, ATMP and JP regulations.
- 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.
The targeted salary range for this position is $60,000 - $75,000 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.
Salary : $60,000 - $75,000
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