Job Details
Sterility Assurance SME Consultant
4959
Posted: 18/09/2024
- $Competitive
- United States, United States
- Contract
Warman O'Brien are proud to partner with a US based Contract Manufacturer (Vaccines/Injectables) seeking a Sterility Assurance SME to ensure sterile practices within the site cleanrooms and within project teams across 3 x US based facilities.
Overview of Assignment:
- Serve as the (SME) and Quality Approver for GxP documentation.
- Review and approve Change Control/Management Documents.
- Drive resolution of sterility-related product complaints, out-of-specifications (OOS), deviations, and corrective actions.
- Develop and implement sterility assurance procedures, sampling plans, and quality audits.
- Coach and Mentor shop floor personnel.
Qualifications & Experience:
- Bachelor's degree in microbiology, pharmacy, or biology
- Minimum of 10 years of experience in microbiology, sterility assurance or aseptic processing
- Experience with regulatory inspections and audits is preferred.
Contract Length: 6+ months
Location: Hybrid, onsite working required across 3 x US based sites
Competitive Hourly Rate: W2 Only
Please click the link below to APPLY!
Lauren McQuade
VP - Contract
+1 617 546 7983
Lauren@warmanobrien.com
Lauren McQuade
Vice President | Contract