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Quality Assurance Specialist III
2 weeks ago
Overview:
- Senior role responsible for planning and implementing quality requirements in manufacturing operations at the site
- Collaborate with subject matter experts to resolve quality issues and improvements for clients
- Review manufacturing batch records in accordance with cGMP
- Review and approve non-conformances, deviations, and CAPAs
- Author and revise departmental SOPs to stay current with regulatory changes
Responsibilities:
- Review and approve Non-conforming events (NCE) and CAPAs
- Review and approve Change Controls, Document Change Requests and Technical Transfers
- Conduct review of Manufacturing batch records efficiently
- Address routine operations and support systems from a quality perspective
- Interact with project teams to translate requirements into manufacturing records
- Participate in audits, regulatory inspections, and process improvement initiatives
- Act as a single point of contact for designated clients
- Attend meetings for representing QA Manufacturing on Quality issues
- Authorized to make decisions on behalf of QA Manufacturing
Qualifications:
- 7+ years of experience in the biopharmaceutical industry
- Bachelor's degree in a Science-related field
New hires must be fully vaccinated against COVID-19 and provide proof of vaccination or receive an approved medical or religious exemption from Human Resources. This offer is contingent upon WuXi ATU verifying vaccination status or approving an exemption request prior to start date.
Our Values:
Integrity & Dedication, Working Together & Sharing Success; Do the Right Thing & Do it Right.
Our greatest asset is our people, WuXi is dedicated to providing opportunities for internal growth with direct access to a dedicated Human Resources team.
WuXi AppTec provides equal employment opportunity regardless of race, color, religion, gender, age, sexual orientation, national origin, disability, or veteran status.
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