Senior Quality Assurance Specialist

Waltham, MA

Posted: 11/28/2018 Employment Type: Contract Industry: Life Sciences Job Number: 227975
Senior QA Specialist 
Contract
6 months to possibility of perm
Greater Boston area 


Projected Description:
  • Batch record review
  • Review of Deviations
  • Labeling & Specifications
  • Assisting with the release of batches
  • Metrics within quality
  • Validation Reports
  • Assist with preparation of audits 
  • Working with CMO's/oversee CMO sites 
  • Experience working with CAPA's
Requirements:
  • Requires a Bachelor’ s degree (engineering or scientific discipline)
  • Experience with Batch record review
  • Quality assurance experience in pharmaceutical industry providing oversight 
  • Ability to translate complex issues into a meaningful set of recommendations that can be understood 
  • Demonstrated knowledge of cGMPs in a manufacturing environment
  • Strong independent judgment and decision-making abilities
  • Demonstrated problem detection and problem resolution skills
  • Must possess demonstrated organizational skills
  • Must possess excellent verbal and written


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