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Quality Assurance Operations Specialist

  • Location: Boston
  • Salary: US$28 - US$32 per hour per hour
  • Job Type:Contract

Posted about 1 month ago

  • Sector: Life Sciences
  • Contact: Mark Watson
  • Duration: 6 Months
  • Expiry Date: 17 August 2022
  • Job Ref: JN -072022-472192

Entry-level opportunity for those with education/prior experience in pharmaceuticals or biotechnology.

Our client is a leading biopharmaceutical company in Boston, Massachusetts with an opening for a 'Quality Assurane (QA) Operations Specialist'. Please refer to the job description below and apply with your most up-to-date resume if you are interested in the role.

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Key Responsibilities

  • Review incoming materials against specifications and submit samples to QC Labs (internal and external) for testing
  • Review and approval analytical protocols/reports, OOS results, re-test plans, etc., and associated corrective and preventive action plans
  • Support non-conformance (OOT/OOS) investigations, CAPAs, risk assessments, change controls associated to in-house testing.

Required Knowledge & Skills

  • Strong leadership skills with the ability to thrive in a high throughput environment
  • Proven experience in raw material release and vendor qualifications program
  • Familiar with Oracle Process manufacturing (OPM) system
  • BS degree required, in the biological or chemical sciences preferred.
  • Demonstrated strong working knowledge of GMP manufacturing.
  • Demonstrated broad working knowledge and experience of regulatory guidance and industry best practice quality control.
  • Experience in leading and supporting investigations and making decisions around issues that arise during data package review.

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Job Title: QA Operations Specialist

Location: Boston, MA

Contract Length: 6 Months, potential to extend

Pay rate: $28-32/hr based on experience.

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