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Quality Assurance (QA) Operations Specialist

  • Job type: Permanent
  • Location: Portsmouth, New Hampshire
  • Salary: US$80000 - US$100000 per year
  • Job reference: 336861/001_1562591089
  • Sector: Quality Assurance, EPM Scientific
  • Date posted: 08/07/2019

Title: Quality Assurance (QA) Operations Specialist

Salary: 80-100k

Summary: A large, industry leading CMO is currently seeking a hardworking, mentally flexible, candidate to fill their Quality Assurance (QA) Operations Specialist role in Portsmouth, NH. You will play a key role in applying good manufacturing Practice (GMP) in a drug substance or drug product manufacturing environment, give on-the-floor QA support, and review Master Batch Records. In addition to that, you will be able to make a direct impact on the firm by helping to grow the Quality Assurance (QA) team. Are you a critical thinker who can adapt to and embrace changed conditions? If yes, please reach out to learn more!

The Quality Assurance (QA) Operations Specialist will be responsible for:

  • Providing quality strategies to ensure compliance
  • Working with change controls and deviation investigations
  • Review and approve Master Batch Records, SOPs, study protocols and summary reports, reports and forms that would be relevant to cell therapy products
  • Work with customers and internal groups to resolve quality issues

The Quality Assurance (QA) Operations Specialist should have the following qualifications:

  • Varied quality background and experience
  • Experience with TrackWise, SAP, LIMS
  • Current Good Manufacturing Practice (cGMP) and ICH guidelines
  • Critical process steps to cell culture and septic processing
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