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Quality Assurance Specialist

2 months ago


Totowa, New Jersey, United States Englewood Lab, Inc Full time
Job Overview

Reporting To: Quality Assurance Supervisor or Manager

Key Responsibilities:

  • Conducts comprehensive Annual Drug Reviews and Device History evaluations.
  • Ensures the maintenance of Regulatory Compliance documentation and external records.
  • Oversees Document Control processes, including Records Retention.
  • Engages in both internal and external audit activities.
  • Participates in Mock product recall assessments.
  • Maintains Standard Operating Procedures (SOPs) and Quality Forms as part of Document Control.
  • Records and manages customer approval documents to ensure authenticity.
  • Participates in Quality Assurance audits and prepares detailed reports.
  • Implements changes to specification sheets following approved change control requests.
  • Supports the Change Control program and maintains documentation of product and process modifications.
  • Updates SOP binders and related documents through approved Change Controls.
  • Facilitates Employee training and documentation for EWL.
  • Administers the qualification program for suppliers and vendors.
  • Supports and oversees approvals for formulary, specifications, and manufacturing records.
  • Engages in Mock product recall assessments.
  • Manages Records Retention for the Quality Assurance Department.
  • Initiates, tracks, and authors Annual Drug Reviews (ADRs) for OTC products and Device History Reviews (DHRs).
  • Assists in the organization, review, and maintenance of OTC bulk batch records, Certificates of Analysis (COAs), and formula documents.
  • Conducts physical sample retain reviews for ADRs and DHRs.
  • Tracks and manages requests for Change Control Notices (CCNs), Defective Material Forms (DMFs), and Deviations, as well as Return Authorizations and Investigations.

Qualifications:

  • Minimum of 2 years of diploma program or a 4-year college degree.
  • 2 to 3 years of relevant industry experience.
  • Prior experience in Pharmaceuticals, Cosmetics, Food, Medical Devices, or related fields.
  • Strong Technical Writing skills.
  • Proficient in Word, Excel, Access, and other Windows-based applications.
  • Excellent record-keeping abilities.

Benefits:

  • Medical, Dental, and Vision Insurance.
  • Life Insurance coverage.
  • 401k matching program.