- 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)
- …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 ... first and quality always. **Position Description:** The Senior / Principal Sterility Assurance Scientist is a technical role that assists in development… 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 (Concord, NC)
- …Concord products, particularly as it relates to development and implementation of sterility assurance strategies, including environmental monitoring, aseptic ... Assurance + 5+yearssupporting cGMP manufacturing (specifically within operations, environmental monitoring, sterility assurance ,validation, microbiology,TSMS,… 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
- Insight Global (Danvers, MA)
- …the Quality Systems team. This role ensures compliance with microbiological quality and sterility assurance standards across manufacturing and product ... -Conduct risk assessments related to microbiological contamination and sterility assurance . -Collaborate with R&D, Manufacturing, and Quality teams to ensure… more
- Element Materials Technology (Eagan, MN)
- …and novel antimicrobial products. In this role, you may also perform sterility and bioburden testing, environmental monitoring, and method qualifications. This ... network of scientists, engineers, and technologists support customers to achieve assurance over product quality , sustainable outcomes, and market access.… more
- Bausch + Lomb (Clearwater, FL)
- …investigations, process/product changes, and new product development. **Sterilization and Sterility Assurance ** + Manage sterilization processes (eg, steam, ... **Documentation & Compliance** + Oversee product release activities, ensuring all microbiological, sterility , and quality criteria are met prior to release… more
- Amgen (Thousand Oaks, CA)
- …cross-functionally with Quality , Validation, and Engineering to ensure sterility assurance standards are consistently met. Responsibilities: **Aseptic ... with current regulatory expectations and site standards. + Partner closely with Quality Assurance , Validation, and other site Aseptic Officers to ensure… more
- Globus Medical, Inc. (Audubon, PA)
- …validations, and deviations. + Support product release and ensure compliance with sterility assurance requirements. Audits, Compliance & Continuous Improvement + ... / ISO 17665. + Ensure control of cleanroom operations, environmental monitoring, aseptic techniques, and contamination control programs. +...5 years of experience is needed within Medical Device Quality Assurance / Quality Systems with… more
- Vanderbilt University Medical Center (Nashville, TN)
- …the longevity and sterility of different types of containment devices. + Quality Assurance (Novice): Performs, documents and monitors all quality control ... for Endoscopy Procedures for all Perioperative areas. **Technical Capabilities:** + Environmental Sterility & Safety (Novice): Possesses sufficient fundamental… more
- Vanderbilt University Medical Center (Nashville, TN)
- …the longevity and sterility of different types of containment devices. + Quality Assurance (Intermediate): Performs, documents and monitors all quality ... all departmental equipment safely and effectively. **Technical Capabilities:** + Environmental Sterility & Safety (Intermediate): Possesses sufficient… more
- System One (Exton, PA)
- …participate in deviations, investigations, and corrective actions. + Collaborate with Quality Assurance to review batch records, resolve out-of-specification ... basis. In this role, you will be responsible for Quality Control activities such as sample review, Environmental...laboratory and the test results meet CSP specifications for sterility , potency, stability of the product(s) manufactured at the… more
- Jabil (Elmira, NY)
- …may include non-conforming product, CAPA, calibration systems, supplier auditing, sterility assurance , and improving measuring techniques, design of ... business success as we strive to build sustainable processes that minimize environmental impact and foster vibrant and diverse communities around the globe. Shift… more