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Quality Assurance Specialist

Newark Metro Area, NJ

Posted: 12/18/2018 Job Type: Scientific Job Number: JN -122018-23262
  • Bachelor s degree, preferably in chemistry, biology, pharmacy or related scientific discipline
  • Minimum of 2 - 4 years QC/QA experience in a CGMP pharmaceutical environment encompassing change controls, training, complaints, non-conformance investigations, CAPA documents and data management
  • The Associate, Quality Assurance is responsible for supporting Quality Assurance (QA) and Compliance related operational activities with a specific focus on QA documentation (e.g., quality complaints, change control documents, SOP s, investigations, and other ad hoc cross-category initiatives.
  • Reviews product batch records to identify and resolve atypical occurrences
  • Prepares, reviews and/or maintains a range of other QA documentation as required
  • Ensures documents are completed in accordance with quality systems SOPs
  • Maintains the complaint data base to prepare and report on metrics for review
  • Authors and reviews new and existing SOP s to further enhance and mature the Quality System
  • Evaluates and enhances departmental and company and/or vendor site quality procedures to ensure compliance with CGMPs and company policies; communicates any compliance issues
  • Prepares yearly audit schedule; performs audit preparation activities for supplier, regulatory, and corporate CGMP audits
  • Maintains and keeps track of files, including SOPs, product disposition documents, non-conformance investigations, extension requests, audits and CAPA
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