Senior Associate Quality Assurance Finished Goods
Senior Associate Quality Assurance Finished Goods
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$ 112000 - 140000
1 Vacancy
Job Description
Why Sarepta Why Now
The promise of genetic medicine has arrived and Sarepta is at the forefront. We hold leadership positions in Duchenne muscular dystrophy (DMD) and limbgirdle muscular dystrophies (LGMDs) and we currently have more than 40 programs in various stages of development in gene therapy RNA and gene editing. In 2023 we launched our fourth therapy and the first ever gene therapy to treat Duchenne.
Were looking for people who see unlimited potential in themselves and who are motivated by an unwavering commitment to patients.
What Sarepta Offers
At Sarepta we care deeply about all the people in our community and believe in the importance of supporting them in all aspects of their lives. We aspire to maintain a culture that acknowledges people bring their whole selves to work and we will strive to help everyone in our community integrate their work and personal lives while maintaining productivity. We are committed to offering a range of benefits and worklife resources designed to support people in the following areas:
Physical and Emotional Wellness
Financial Wellness
Support for Caregivers
For a full list of our comprehensive benefits see our website: Importance of the Role
The Sr. Associate will be responsible for daytoday activities related to product disposition including review/release of finished good batch records maintain applicable tracking and metric logs attend CMOs meetings general QA support for deviations and investigations and CAPA activities. In addition he/she will be responsible for ensuring Sareptas quality policies practices procedures standards and systems for necessary adherence to aseptic production and product management in accordance to the cGXP compliance to US ATMP and EU regulations are being maintainedThe Opportunity to Make a Difference
- 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.
More about You
- BS/MS or relevant/equivalent industry experience in scientific discipline preferred and 46 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
- Candidate will be expected to interact with CMOs and other groups across Sarepta.
- 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
What Now
Were always looking for solutionoriented critical thinkers.
So if youre comfortable with ambiguity and candor relish challenging yourself and place kindness and integrity at the forefront of how you approach your peers and work then we encourage you to apply.
Required Experience:
Senior IC
Employment Type
Full-Time
