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Quality Assurance Specialist

Company: Coda Staffing
Location: Boonton
Posted on: February 22, 2021

Job Description:

ResponsibilitiesPerforms QA oversight of Production activities including Compounding, Filling, Inspection, Labeling and Packing. Oversight and confirmation of cleaning of rooms, parts, equipment and surfaces to assure compliance with cleaning requirements

  • Oversight and confirmation of compliance in Compounding processes including room clearance, verification of material status, weighing, mixing, charging of chemicals, in-process quality attributes, autoclave, compliance with batch record instructions and sequence, documentation verification, logbook documentation verification.
  • Oversight and confirmation in compliance of Filling Operations including line clearance, material status, aseptic technique, in-process quality attribute testing, documentation on forms and batch records.
  • Verification of proper gowning by all personnel in all areas of Production.
  • Verification of environmental monitoring activities including plating, Lighthouse and personnel monitoring.
  • Generation of deviations, issuance of CAPAs, Change Controls in response to observations
  • Follow up with Quality Assurance Management on quality issue tracking and trending activities also include batch record review, batch release, visual inspection and any other activity assigned by Quality Assurance management.
  • Oversee all Quality aspects on the floor
  • Product label review and approval
  • Participate in regulatory audits
  • Performs or assists process owners with root cause analysis
  • Prepares and monitors Quality Metrics and KPI's
  • Performs duties in accordance with established company procedures and policies; performs other duties as assigned.Qualifications
    • 3 plus years' experience with aseptic drug product manufacturing is required.
    • A fundamental, working knowledge of safety, quality systems, and quality assurance concepts is required including the application of current Good Manufacturing Practices and Good Documentation Practices.
    • Strong familiarity with manufacturing process and operations, automation, equipment/facilities validation
    • Familiarity with FDA inspections and audits
    • Investigation writing skills.
    • Ability to complete tasks with little direction or need for supervisory follow-up.
    • Strong written, verbal and presentation communication skills.
    • Strong computer skills in database management and documentation preparation (Word, PowerPoint, Excel, and other must be able to learn additional software as required).
    • Ability to think creatively in confronting new issues and pursuing novel approaches to old problems.
    • Ability to work under pressure, meet deadlines and exercise sound business judgment with critical thinking skills and high ethical standards.
    • Work schedule flexibility.Experience:
      • 3-5 years of progressive experience within cGMP quality operations and FDA regulations or a 503B outsourcing facility, aseptic/parenteral manufacturing/development environment or equivalent technical experience.
        Education/Training
        • High school degree
        • BS in Scientific field preferred

Keywords: Coda Staffing, Paterson , Quality Assurance Specialist, Other , Boonton, New Jersey

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