Quality Assurance Manager Job at Albion Rye Associates, New Jersey

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  • Albion Rye Associates
  • New Jersey

Job Description

Job Title: Manager, Quality Assurance

Location: New Jersey (On-site)

 

Position Summary:

We are looking for an experienced and knowledgeable Quality Assurance Manager to lead and support a range of quality-related activities. This includes ensuring cGMP compliance, managing SOP and training systems, overseeing QA/QC testing procedures, and making quality and compliance decisions for a diverse range of products, including generic pharmaceuticals, dietary supplements, and medical foods.

 

Key Responsibilities:

  • Conduct and support third-party audits of current and proposed vendors to assess cGMP compliance.
  • Manage and maintain the SOP system, including drafting, revising, tracking, and training on SOPs.
  • Oversee market distribution activities for product batches.
  • Review and resolve batch deviations, Out-of-Specification (OOS) reports, and proposed Corrective and Preventative Actions (CAPAs) from manufacturers related to Dietary Supplements and Medical Foods.
  • Handle product quality complaints and implement resolutions.
  • Support regulatory audits and inspections, including those conducted by the FDA, for the organization and its manufacturing partners.
  • Conduct Product Quality Reviews, including evaluating manufacturers' annual product review reports.
  • Manage change control processes for Dietary Supplements and Medical Foods.
  • Perform batch record reviews as required.

 

Qualifications and Experience:

  • Bachelor’s degree in a technical or scientific discipline (e.g., biology, chemistry, pharmacy, or related field).
  • Minimum of 7 years of experience in the pharmaceutical industry, with a focus on Quality Assurance and Quality Systems.
  • At least 2 years of experience in a management role within QA is preferred.
  • Strong understanding of cGMP compliance and quality standards for pharmaceutical products.
  • Willingness to travel domestically to contract manufacturing sites, with potential international travel for audits.

Job Tags

Permanent employment, Contract work,

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