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Back To Current Job Listings: QUALITY ASSURANCE ASSOCIATE
QUALITY ASSURANCE ASSOCIATE
[Jun 21, 2019]

JOB SUMMARY:

 

Under supervision of the Sr. Director, Quality Assurance, the Associate, Quality Assurance will support documents review, the company SOPs and training management, and market distribution of batches.

 

DUTIES AND RESPONSIBILITIES: 

 

  • Support management of the SOP system, including writing/revising and maintaining SOPs, SOP Tracking and SOP Training
  • Participate in the internal tracking of manufacturers’ change controls
  • Support product quality complaints system including classification of complaints, complaint response letters issuance and notification to manufacturers, as required
  • Participate in the QA review and internal product launch process for ANDA drug product, OTC, Dietary Supplement and Medical Food products
  • Product Quality Reviews, including review of manufacturers’ reports of annual product reviews, as required
  • Metrics reporting
  • Market distribution process
  • Batch record reviews, as required

 

ESSENTIAL QUALIFICATIONS, EDUCATION AND EXPERIENCE

 

·         BS required (preferably technical / science-biology, chemistry, pharmacy or other suitable science/technology)

·         Minimum 2 years’ experience in the pharmaceutical industry with focus in Quality Assurance / Quality Systems

 

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