- Genentech (Hillsboro, OR)
- …to bring transformative therapies to patients. This role is a vital part of our Environmental / Sterility Quality Assurance team, dedicated to ensuring the ... shaping a culture of continuous improvement and excellence. **The Opportunity** As an Environmental / Sterility Quality Assurance (EQA) Specialist, you… more
- Lilly (Lebanon, IN)
- …(specifically within operations, environmental monitoring, sterility assurance validation, microbiology laboratory, TS/MS, quality assurance , ... assurance related initiatives and provides technical leadership with regard to sterility assurance & environmental monitoring strategies. Primary… more
- Lilly (Pleasant Prairie, WI)
- …products within operations, microbiology, environmental monitoring, sterility assurance , validation, technical services, and/or quality assurance ... determined to make life better for people around the world. **Responsibilities:** The Sterility Assurance Scientist is a technical role that assists in… more
- Lilly (Pleasant Prairie, WI)
- …readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance issues. + ... readiness activities; interact with regulatory agencies during inspections regarding cGMP, environmental monitoring, and sterility assurance programs.… more
- Lilly (Concord, NC)
- …products within operations, microbiology, environmental monitoring, sterility assurance , validation, technical services, and/or quality assurance ... determined to make life better for people around the world. **Responsibilities:** The Sterility Assurance Scientist is a technical role that assists in… more
- Lilly (Indianapolis, IN)
- …and provides technical leadership with regard to sterility assurance strategies. **Responsibilities:** + Ensure site's Environmental Monitoring, Aseptic ... environmental monitoring data in addition to other sterility assurance periodic reviews. + Lead or...trends. + Participate in continuous improvement projects to improve quality performance at the site. + Participate or provide… more
- Lilly (Raleigh, NC)
- …in a biological science preferred. + 10+ years' experience working in Parenteral Sterility Assurance / Environmental Monitoring or equivalent roles ... the world. Lilly is working to build a stronger Sterility Assurance function and capability to provide...to Lilly, to ensure strategies are in-line with technical, quality and regulatory guidance, current expectations and business needs.… more
- ThermoFisher Scientific (Greenville, NC)
- …a comprehensive background check, which includes a drug screening. **POSITION SUMMARY** The Sterility Assurance Manager is accountable for sterility ... **Work Schedule** First Shift (Days) ** Environmental Conditions** Adherence to all Good Manufacturing Practices...future expectations + Lead sophisticated investigations into issues impacting Sterility Assurance (ie Adverse EM trends, media… more
- Integra LifeSciences (Mansfield, MA)
- …and guidelines, for example knowledge on ISO 11137, ISO 11135 and environmental monitoring requirements. + Supports EU MDR compliance by performing gap analysis ... changes. + Provides guidance and input on the resolution of sterility related non-conformances + Supports sterilization validations, cleaning validations, and… more
- Bristol Myers Squibb (Indianapolis, IN)
- …duties and responsibilities include the following. Other duties may be assigned. . Quality Assurance support and oversight of QC (Analytical and Microbiological) ... validation, and transfer activities, equipment validation work and associated projects. . Quality Assurance support of QC associated with the manufacturing… more
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