Quality Assurance Manager Job at Albion Rye Associates, New Jersey

b1dwdXJQQVlBTnllcVVPTWtsaGhaeFZW
  • 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,

Similar Jobs

EMI Enterprises, Inc.

CDL Class A Truck Driver Job at EMI Enterprises, Inc.

CDL Class A Truck Driver Are you an experienced CDL Class A Truck Driver - looking for a new opportunity with a company that values its drivers and provides great benefits? Look no further! We are seeking a dedicated and reliable driver to join our team. Why Join ...

Rutland Regional Medical Center

Preregistrar Job at Rutland Regional Medical Center

 ...knowledge of basic computer skills and Basic Microsoft Windows desktop application and navigation. Ability to discretely handle confidential information. Demonstrated strong knowledge of insurance plans preferred. Ability to apply experience and knowledge to... 

VitalCore Health Strategies

Registered Nurse Job at VitalCore Health Strategies

 ...VitalCore Health Strategies, (VCHS), an industry leader in Correctional Health Care, has openings for Registered Nurses at Sheriff Al Cannon Detention Center in North Charleston, South Carolina for Multiple Shifts ! We offer shift differential pay for the... 

Meet Life Sciences

Director, Pharmacovigilance Job at Meet Life Sciences

 ...Director, Pharmacovigilance *Hybrid Opportunity (2-3x per week onsite in Redwood City, CA)* Meet has partnered with an exciting biotech in the rare disease space that is looking for a Director of Pharmacovigilance/Drug Safety to join their team. Key Responsibilities... 

OLX

Product Designer - Design System (m/f) Job at OLX

 ...trade.We make it safe, smart, and convenient to buy and sell cars, find housing, get jobs, buy and sell household goods, and more....  ...in Portugal). Full remote working in Portugal is possible.Our Design team is on a mission to transform how we build products at OLX Group...