Quality Disposition Specialist II (Biopharma)
ACTalent
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Benefits offered by this job
Job summary
Actalent is seeking a Quality Specialist II to support product disposition activities and ensure compliance with quality systems and cGMP requirements. The role collaborates across QA, Manufacturing, and Regulatory Affairs to review batch records, assess product impact, and support release decisions.
The ideal candidate has experience in a regulated biopharmaceutical, pharmaceutical, or biotechnology environment, with strong skills in batch record review, deviation investigations, and quality
Qualifications
- Advanced degree plus 2 years of QA/QC/Manufacturing experience in a regulated biopharma or biotech environment.
- Bachelor’s degree plus 3 years of experience in a related function within a regulated setting.
- Strong knowledge of cGMP regulations and industry guidance for biologics/pharma.
Responsibilities
- Review manufacturing and quality documentation and assess product impact.
- Investigate quality issues and support product release decisions.
- Collaborate with cross-functional teams across QA, Manufacturing, and Regulatory Affairs.
- Evaluate batch records, deviations, CAPA and change controls for disposition.
- Ensure quality decisions are documented with clear rationale and data traceability.
Skills
Education
Tools
Job description
Actalent is seeking a Quality Specialist II to support product disposition activities and ensure compliance with quality systems and cGMP requirements. The role collaborates across QA, Manufacturing, and Regulatory Affairs to review batch records, assess product impact, and support release decisions.
The ideal candidate has experience in a regulated biopharmaceutical, pharmaceutical, or biotechnology environment, with strong skills in batch record review, deviation investigations, and quality
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