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.

Apply

Vacancy posted 2 days ago

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