Aseptic Product Quality Manager
Intellectt INC
Job Title: Aseptic Product Quality Manager
Location: Rochester, NY (Hybrid)
Duration: 12+ Months
Job Summary:
Seeking an experienced Aseptic Product Quality Manager to provide Quality SME support for aseptic manufacturing, investigations, product transfers, and external manufacturing operations.
Key Responsibilities:
- Lead Quality activities for aseptic manufacturing and third-party manufacturing operations.
- Support aseptic event investigations, risk assessments, root-cause analysis, and CAPA.
- Drive implementation of aseptic manufacturing best practices and continuous improvement.
- Support final product lot release and product quality decisions.
- Manage Quality and Technical Agreements and ensure compliance commitments are met.
- Support audits, site approvals, due diligence, and regulatory inspection readiness.
- Lead Quality activities for product launches and manufacturing transfers.
- Review quality trends, deviations, CAPA, APR/APQR, and management-review activities.
- Partner with Quality, Manufacturing, R&D, Regulatory, and external manufacturing teams.
Qualifications:
- Bachelor's degree in Life Sciences, Engineering, Pharmaceutical Sciences, or related field.
- 5+ years of experience, including 5+ years in Quality Assurance and/or aseptic manufacturing.
- Strong knowledge of aseptic manufacturing, cGMP/GxP, quality systems, investigations, CAPA, and risk management.
- Experience with pharmaceutical, biological, sterile, liquid, solid, or medical device products preferred.
- Strong analytical, problem-solving, communication, and cross-functional leadership skills.
Vacancy posted 2 days ago
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