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QA Specialist

Company: Joule
Location: Hightstown
Posted on: May 5, 2021

Job Description:

Title: QA Specialist Location: East Windsor, NJ Schedule: M-F, 8-5 (8hr day) some OT needed on occasion during week and possible on weekend if needed. Type: Temporary Start date: ASAP Responsibilities:

  • Responsible for reviewing specifications, procedures, protocols, and records for GMP compliance.
  • Responsibilities also include GMP audits of the plant, coordinate and track closeouts of deviations, change control requests, consumer complaints, and out-of-specification investigations.
  • Perform review of batch production and control records for OTC products and initiate investigation for any unexplained discrepancy found during review.
  • Prepare Certificate of Manufacturing and Compliance and release OTC products for shipment.
  • File and maintain batch production and control records for OTC product.
  • Review raw material, packaging material, in-process material and finished product specifications for GMP compliance - Reconciliation of OTC Batch Records.
  • Prepare master production records for all OTC products if assigned.
  • Coordinate and track completion of action items generated due to deviations and change control requests
  • Provide assistance writing OOS, Consumer complaint investigation, metrics reports. Present data through meetings and as written documents. Propose appropriate CAPAs to avoid reoccurrences.
  • Administers CAPA system focusing on CAPA approval, closure and database tracking.
  • Conduct Internal Quality Audits. Report observations and other potential concerns to the auditees and management, both through verbal presentation and written audit reports.
  • Conduct Annual Product Review of OTC products.
  • Provide GMP Training to other departments as needed
  • Researches and prepares data needed for monthly quality metrics reporting
  • Assist in any project/task assigned by the Manager. Requirements:
    • BS Bachelor's degree preferably with a Engineering or Science major.
    • Must have minimum of Two years knowledge of pharmaceutical GMP documentation requirements
    • Must have 2-4 years experience quality assurance experience in a regulated industry (cosmetic or pharma or related) including: Batch record review/reconciliation, CAPA.OOS
    • Must have good understanding of 21CFR (Part210-211), ICH guidelines
    • Expert in Excel and PowerPoint presentation Good presentation skills.
    • Must have batch record review experience Joule, a System One division is a leader in specialized workforce solutions and integrated services. With more than 6,000 employees and roughly 50 offices throughout the U.S. we provide scientific, clinical, engineering, energy, IT, legal and administrative staffing services. For more than 40 years, we have delivered workforce solutions and integrated services to clients nationally.

Keywords: Joule, Trenton , QA Specialist, Other , Hightstown, New Jersey

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