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Our client is a leader in the pharamceutical/biopharmaceutical industry!  They are in need of a Quality Specialist for their R&D program.
 
Responsibilities:

  • Assists in developing, implementing and maintaining a specialized quality system to support the R&D programs including quality assurance for GMP and GLP supplies.
  • Oversee and coordinates investigations, provides direction and guidance for investigations and executes them when needed.
  • Provide Quality Systems support for complex technical projects and in troubleshooting activities.
  • Assist with CDMO and product technical transfers to commercial state.
  • Assist in building, maintaining and continuously improving a specialized quality system to support R&D and CDMO programs.
  • Ensure Good Manufacturing Practices (cGMP) compliance in such areas as batch production and record review and retention.
  • Answers customer communications and helps build a customer support program.
  • Reviews completed batch records for completeness, accuracy and compliance to process parameters.
  • Actively participates as quality support to R&D and the manufacturing departments that is performing the technical transfer.
  • Completes Deviations and CAPAs as needed.

Requirements:

  • Bachelor's Degree in Chemistry or related field highly preferred.
  • 4+ years of similar experience in the pharmaceutical/biopharmaceutical industry.
  • Experience with GMP, GLP, cGMP, and SOPs.

Salary : $60,000 – $85,000

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