Quality Operations Specialist
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.