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QA Release Coordinator - 2nd shift

Company: Renaissance LLC
Location: Lakewood
Posted on: November 17, 2020

Job Description:

Renaissance LLCAll qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or other legally protected status.Overview

The QA Release Coordinator will coordinate Quality Inspector activities. Support manufacturing services through the review and release of Raw Materials and Components per cGMP and company standards. Ensure Quality Assurance Standards and procedures are met as well as promote continuous improvements. Review and approve conditional release and final release of ASCNs. Provide support documentation during GMP audits. Interact with internal and external clients in preparation for new products (development, clinical and commercial) manufactured at Renaissance. This is a 2nd shift position (3:00 pm to 11:30 pm)

Responsibilities

  • Responsible for supporting manufacturing services through the review and release of Raw Materials, Components.
  • Coordinate the segregation/delivery for all sample requests.
  • Write, review, analyze and revise Standard Operating Procedures (SOPs) and submit procedural changes as needed.
  • Coordinate training of processes and procedures for line inspectors.
  • Provide support documentation during client audits and regulatory inspections.
  • Review and approve conditional release and final release of ASCNs.
  • Check and verify documentation for accuracy and completeness namely packaging log books, filling records, packaging records etc.
  • Support process improvement teams within the company.
  • Utilize investigative techniques to assist with determining root causes of deviations and assist with determining the proper corrective and preventive actions.
  • Support Non-CDS and CDS drug retain program.
  • Coordinate scheduling and facilitate transitions between shifts.
  • Perform product holds, tagging and un-tagging of non-conforming material in a timely manner.
  • Interact with other departments and customers to address investigations and customer questions.
  • Perform QA line inspector role if required.
  • Any other tasks assigned by management.

    Qualifications

    Education:

    Two years of advanced education preferred.

    Experience:

    A minimum of 10 years of relevant experience in the pharmaceutical industry in a Quality Systems or Quality Assurance environment PI126001958

Keywords: Renaissance LLC, Lakewood , QA Release Coordinator - 2nd shift, Other , Lakewood, New Jersey

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