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Quality Assurance Specialist

  • Job type: Permanent
  • Location: Burlington
  • Salary: $60000 - $75000 per annum
  • Job reference: BD0801171
  • Sector: EPM Scientific, Quality
  • Date posted: 08/08/2017
Quality Assurance Specialist needed for Global CRO/CMO!
A rapidly expanding global CRO/CMO is looking to hire Quality Assurance Specialist to support the QA organization, specifically the cGMP Compliance function, in Burlington, MA. 

The company strives for organic growth, so career development for this individual is uncapped. This position works closely with other departments and groups in order to maintain high levels of cGMP compliance in all regulated activities. The ideal candidate will be a highly organized self-motivator, and be well versed in all cGMP activities.

The Quality Assurance Specialist will have the following responsibilities:
  • Un-executed/Executed batch record review & QC testing for compliance with internal SOPs
  • Review and approve SOPs, test methods, raw material specifications, and validation documentation
  • CAPAs, Deviations, Change Controls, Equipment Excursion Reports
  • Manufacturing area and label clearances, inspection of material
  • Internal/External audits, assists in performing investigations and participates in regulatory and client audits
The ideal candidate will have the following skill set:
  • Strong cGMP knowledge and facilitation skills
  • 4-6 years experience in Pharmaceutical/Biotech industry, 2+ years of QA experience
  • Strong problem-solving skills, conflict resolution
  • Excellent written, communication, & verbal presentation skills
  • Analytical experience is preferred, but not a must-have


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