- Repligen (Waltham, MA)
- …with eQMS systems or digital audit tools Familiarity with regulatory standards ( FDA , GMP , etc.). Excellent communication, negotiation, and interpersonal skills. ... Willingness to travel for supplier audits and evaluations.What Repligen OffersRepligen offers you a competitive remuneration package, including a yearly bonus, non-contributory pension, generous PTO, partial compensation on your personal health insurance and… more
- Aequor (Athens, GA)
- …laboratory environment. Preferably experience with Documentum, MS Teams, MS Sharepoint. 21CFR Part 11, GLP ( FDA and EPA), GMP ( FDA and EU), VICH Internal BI ... policies on Records Management, Training Management, Information Protection. The individual must be very detail oriented and able to follow precise instructions. Understanding of typical pharmaceutical and/or biological development processes and documentation… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …compliance, clinical quality, or cell therapy.Knowledge of cGMP regulations and FDA /EU guidance related to GMP manufacturing of biopharmaceuticals.Experience in ... plant to support both clinical and commercial requirements in a sterile GMP environment. This role will also provide oversight of technical, qualification, and… more
- Merck & Co. (Rahway, NJ)
- …under pressure.Demonstrates strong attention to detail.Process-oriented with familiarity of GMP requirements and working in a highly regulated industry.Experience ... Documentation requirements and processes pertaining to system management for GxP/ GMP applications.Current Employees apply HERE Current Contingent Workers apply HERE… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …GMP Compliance & Regulatory Knowledge: Deep understanding of FDA , EMA, and other global regulatory requirements for pharmaceutical manufacturing.Operational ... to prepare for tomorrowTrack record of successfully leading audits and inspections ( FDA , EMA, etc.)An ability to build strong partnerships and effectively integrate… more
- Merck & Co. (Rahway, NJ)
- …is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in ... options, technology selection and regulatory postureDemonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC.- Strong experience… more
- Merck & Co. (Rahway, NJ)
- …phase and/or late phase drug product manufacturing processes to GMP production facilities.Experience authoring regulatory filings, and demonstrated working knowledge ... of FDA , ICH, and other regulatory requirements for CMC.- Strong understanding of integration and partnering with Quality, Regulatory, Operations, Non-clinical,… more
- Novo Nordisk Inc. (West Lebanon, IN)
- …ensure operational efficiencies and successful production of API onsite. Prior experience in a GMP environment or life science industry is a plus for this role. This ... and validated in a compliant manner in accordance with FDA , EU and NN requirements Actively participate on cross...systems are completed in a manner in compliance with FDA , EU and NN regulations Responsible for the verification… more
- Eisai, Inc (Raleigh, NC)
- …a plus). Demonstrated experience across applicable quality assurance functions in a GMP setting (eg, batch record review, SOP writing, auditing, batch release ... and resolution, as applicable) .Familiarity with applicable regulatory requirements (eg, FDA , EMA, ICH) and quality systems.Strong oral and written communication… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …devices, circuits, and switchgear used in cGMP and non GMP systemsInvestigate, troubleshoot, and provide repairs to equipment, instruments, instrumentation ... federal regulations including and equivalent to Federal Drug Administration ( FDA ), Environmental Protection Agency (EPA), Occupational Safety and Health… more
- Sanofi Group (Framingham, MA)
- …was possible. Ready to get started? **Main Responsibilities:** . **Ensure US FDA GMP Inspection Readiness, Inspection Activities, Inspection Follow-Up** for US ... readiness and effective response management. + Provide direct support to US FDA GMP inspections on-site to ensure successful outcomes. + In collaboration with… more
- Sanofi Group (Morristown, NJ)
- …science, or equivalent + Experience preparing for and direct support of US FDA GMP Pre-Approval Inspections, and follow up activities (eg, inspection response ... **Job Title:** Global Quality Lead, GMP , GDP Audit and Inspection - Pipeline Launch...+ Covers an international scope including major regulators; US FDA (USA), EMA (Europe), ANSM (France), National Medical Products… more
- Novo Nordisk (Bloomington, IN)
- …automated manufacturing equipment. + Partner with commissioning and validation teams to meet FDA GMP compliance. + Draft, revise, and maintain standard operating ... oversight, and continuous improvement of automation systems that support our GMP manufacturing operations. This position focuses on process control systems, with… more
- System One (Fairfield, NJ)
- …during testing protocols Regulatory Compliance & QA Program Management + Ensure adherence to GMP , HACCP, and FDA food safety requirements at all times + ... within a food, flavor, or dairy manufacturing environment + Familiarity with FDA , GMP , HACCP, and regulatory compliance requirements + Proficiency in… more
- Keurig Dr Pepper (Sacramento, CA)
- …the facility to ensure that the plant is fully operating in compliance with FSMA, FDA GMP , OSHA, EPA regulations and GFSI guidelines. + Lead the root cause ... defined by FSMA, six sigma Quality performance, and 100% compliance to all FDA , EPA and OSHA regulations. **Location:** This position is located at our Sacramento,… more
- Herbalife (Winston Salem, NC)
- …for this position. **Experience:** + A minimum of 1 year of experience in FDA or GMP regulated industry **Education:** + High-school diploma (or equivalent) ... rejected, hold, etc. + Document quality-related incidents using appropriate GMP documentation (eg, nonconforming materials report, unplanned deviation report,… more
- Herbalife (Winston Salem, NC)
- …operate these lifts. Experience: + A minimum of 1 year of experience in FDA or GMP regulated industry Education: + High-school diploma (or equivalent) PREFERRED ... rejected, hold, etc. + Document quality-related incidents using appropriate GMP documentation (eg, nonconforming materials report, unplanned deviation report,… more
- Performance Food Group (Sioux Falls, SD)
- …you will do** + Must be willing to learn and become knowledgeable in SQF, USDA/ FDA regulations, GMP 's, Food Safety, HACCP & SOPs. + Maintain, organize and assist ... will be compliant with current regulations pertaining to SQF, USDA, HACCP, FDA , SOP's and GMP 's. + Have the ability and knowledge to read and understand… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …updated, and maintained as required by internal Quality Policies and related FDA / GMP guidelines. The Associate Scientist conducts product testing, potential ... make independent decisions. + Preferred knowledge of the following industry regulations FDA (Food and Drug Administration), GMP (Good Manufacturing Practice) /… more
- Kelly Services (Jacksonville, FL)
- …non-clinical and clinical lenses. + Maintain accurate documentation to ensure adherence to GMP , FDA and ISO regulations. + Assist technical services in executing ... lenses. + Maintains lot integrity and control to ensure compliance with FDA , GMP , ISO and company requirements. + Solution Preparation and Solution testing. +… more