Englewood Lab

Quality Assurance Associate- (Quality)

Englewood Lab Totowa, NJ
Englewood Lab

Quality Assurance Associate- (Quality)

Englewood Lab Totowa, NJ
2 months ago 33 applicants

See who Englewood Lab has hired for this role

  • Conducts Annual Drug (Product) Reviews and Device History Reviews
  • Maintains Regulatory Compliance documents and documents of external origin
  • Maintain Document Control (including Records Retention)
  • Participates in internal and external audit process.
  • Participates in Mock (product) recall audits
  • Maintain SOPs and Quality Forms as part of Document Control
  • Maintains records of customer-approvals documents as evidence of authenticity
  • Participate in QA Audits and draft reports of such audits.
  • Effects changes to specification sheets as approved through change control requests
  • Support Change Control program and maintain evidence of product and process changes
  • Maintains SOP binders and updates such documents through approved CCs
  • Supports EWL Employee training and documentation
  • Maintains suppliers and vendors qualification program
  • Supports and maintains approvals of formulary, specifications and manufacturing records
  • Participates in Mock (product) recall audits
  • Maintains Records Retention for QA Dept
  • Initiates, Tracks, and authors Annual Drug Reviews (ADRs) for OTC and Annual Drug Reviews and Device History Reviews (DHRs)
  • Assists in collating, reviewing, filing, maintaining of OTC bulk batch records, COAs, formula documents, etc
  • Tracks and Performs physical sample retain review for ADRs and DHRs
  • Tracks, Maintains, Closes requests for Change Control Notices (CC), Defective Material forms (DMF), and Deviations, Return Authorizations, Investigations, etc


Requirements

  • Minimum of 2 years of diploma program or 4-year college degree
  • 2 to 3 years industry or related experience
  • Previous experience in Pharma, Cosmetics, food, medical device, or allied profession
  • Good Technical Writing ability
  • Excellent knowledge of Word, Excel, Access, and other Windows-based programs
  • Good record-keeping skills


Benefits

  • Medical, Dental, and Vision Insurance
  • Life Insurance paid 100% by the company
  • 401K after 6 months

  • Seniority level

    Associate

  • Employment type

    Full-time

  • Job function

    Quality Assurance

  • Industries

    Primary and Secondary Education and Non-profit Organizations

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