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Quality Assurance Manager - GMP

EPM Scientific Cleveland ,OH
  • Expired: over a month ago. Applications are no longer accepted.
Job Description

QA Manager

  • Cleveland OH area

A leading API manufacturer is actively seeking a QA Manager to join their rapidly expanding team. This role reports directly to the Site General Manager and will work closely with the technical operations team. The QA Manager will be responsible for the compliance of quality systems, identifying system improvements, and oversight at the project level.

The QA Manager will have the following responsibilities:

  • Reviewing all quality documentation related to the manufacturing and characterization of various drug products and substances
  • Administrate audits to ensure compliance of operational activity
  • Manage all supplier and material qualifications to support a GMP manufacturing environment
  • Work closely with the QMS database to handle change control, deviations, and CAPAs
  • Manage a team of 4-5 QA staff

The QA Manager should have the following qualifications:

  • Bachelors Degree with 7+ years experience within the Biotechnology/Pharmaceutical industry
  • 5+ years of QA experience in a small molecule manufacturing environment
  • Knowledge of GMP and GLP principles
  • Strong management and communication skills
  • Working knowledge of the drug development process

EPM Scientific

Address

Cleveland, OH
USA