Quality Operations Specialist

  • Type: VMS
  • Job #39712
  • City: Rahway
  • State: NJ

Seeking a Quality Specialist for our client – a leading global pharmaceutical company who specializes in developing and manufacturing a variety of well-known pharmaceutical drugs, vaccines and animal-health products.

Type: Hybrid. Must be able to commute to Rahway, NJ 3-4 times a week.

Terms: One year contract, possibility of extension.

Hours: Monday – Friday 8 AM-5 PM.


  • Support Operational Readiness of the new labs sterile clinical manufacturing facility.
  • Work closely with Operations partners to develop processes and procedures which meet all internal and external quality and compliance requirements.
  • Serve in the lead (or co-lead) role for Quality Risk Assessments.
  • Work with Operations partners to develop the Plan for each risk assessment.
  • Schedule and run cross-functional risk assessment meetings.
  • Responsible for reporting the outcomes of the risk assessment. This includes a written report (risk assessment) and a presentation to the appropriate Decision Makers.
  • Support other aspects of Operational Readiness, as it pertains to quality deliverables (authoring or reviewing documents like SOP’s, training materials etc. Designing and/or utilizing project management tools to track progress.)


  • BS (+4 years of experience) or MS degree (+2 years of experience) with technical emphasis in an appropriate scientific or engineering field preferred
  • Project Management experience or Quality Risk Management experience. Combination of both ideal.
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