- Merck & Co. (Rahway, NJ)
- …ICH, and other regulatory requirements for CMC.- Strong experience in safety and environmental knowledge and site presence.- -Excellent verbal and written ... Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to… more
- Merck & Co. (Durham, NC)
- …for daily support and oversight of all production processes to ensure compliance with regulatory requirements as well as policies and procedures.Responsible ... for establishing processes that ensure required safety guidelines are followed.Review and approve qualification/validation documents for equipment and process (ie,… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …federal regulations including and equivalent to Federal Drug Administration (FDA), Environmental Protection Agency (EPA), Occupational Safety and Health ... systemsPerform on-site equipment maintenance and critical utilities maintenance operations, and compliance . This includes but is not limited to: support to… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …personnel. Additionally, you will implement testing standards, policies and ensure safety measures are followed. The supervisor will assist laboratory personnel with ... documentation.Help with the implementation and interpretation of applicable quality and regulatory requirements (eg, FDA, GLP, QSR, cGMP, USP, and CDR rules,… more
- Merck & Co. (Durham, NC)
- …yield/efficiency, reduce cost, or lower our processing cycle times. Supports team safety , environmental , and compliance objectives. Manages project and ... lead. Supports and/or executes continuous improvement projects that increase compliance , simplify/ standardize and/or gain efficiencies. Provides technical support… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- … status and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policiesPerform other duties ... and completing associated documentation in support of producing pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. This position… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …reports are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policies Perform other ... The SQE Manager, QA Compliance , is responsible for managing the Supplier Quality...compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration.Job… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policiesPerform other duties ... documentation in support of inspecting, packaging and/or labeling pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. The Group… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …products in compliance with local procedures, corporate policies, and the regulatory requirements of the US Food and Drug Administration. The individual will be ... management, (ie, QC-Microbiology Supervisor) and will provide both laboratory and/or environmental monitoring leadership as part of the Microbiology group. The… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …personal training compliance status with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policiesPerform ... documentation in support of inspecting, packaging and/or labeling pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. This position… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policiesPerform other duties ... Good Documentation Practices (GDocP)Supervise Finishing activities to ensure operational efficiency, regulatory compliance , safety and production goals are… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental and company policiesPerform other duties ... and completing associated documentation in support of producing pharmaceutical products in compliance with all safety policies, cGMPs, and SOPs. The Supervisor,… more
- Merck & Co. (Durham, NC)
- …walkthroughs, 5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required . - Self-motivated to ... people that make our products. We work in the manufacturing plants with a " Safety First, Quality Always" mindset striving for continuous improvement. We work in the… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …the industry.Job Responsibilities: Maintain compliance with company policies, cGMP, safety standards, and regulatory requirements. Operate equipment on the ... with a team of manufacturing professionals and performing aseptic interventions, environmental monitoring, and other microbiology and operational tasks. This newly… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …industry. Job Responsibilities:Maintain compliance with company policies, cGMP, safety standards, and regulatory requirements.Operate equipment on the ... leading a team of manufacturing professionals and performing aseptic interventions, environmental monitoring, and other microbiology and operational tasks. This role… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental , and company policies.Perform other duties ... The Project Manager II is responsible for being in compliance with all safety policies, cGMPs, and...responsible for being in compliance with all safety policies, cGMPs, and SOPs.Job Responsibilities:Manage large-scale, complex projects… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …are trained and work in compliance with applicable SOPs, cGMPs, regulatory requirements, safety , environmental , and company policies.Perform other duties ... The Project Manager I is responsible for being in compliance with all safety policies, cGMPs, and SOPs.Job Responsibilities:Manage the end-to-end delivery of… more
- Merck & Co. (Durham, NC)
- …5S, kaizen events, or any other operations, lean six-sigma, quality, safety or environmental training/initiatives as required. Self-motivated to maintain ... hands-on training Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements Demonstrated ability to work both independently and as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …team that supports daily production of a CAR-T manufacturing facility.Maintains safety standards and training in the department; ensures that the building ... in a clean and safe manner which includes performing monthly operational/ safety inspections Supervises maintenance personnel to ensure all corrective and preventive… more
- Twist BioScience (South San Francisco, CA)
- …of public and common areas by conducting "walk-throughs" of site to ensure compliance with local health and safety regulations Model company safety ... duties and projects as assigned by department head Follow regulatory and ISO 13485 requirementsWhat You'll Bring to the...with vendor management and the implementation of the corporate safety program Experience with Environmental Health &… more
