- Bristol Myers Squibb (Devens, MA)
- …+ Review all data in accordance with applicable procedures and cGMP requirements. + Anticipate and troubleshoot problems. Communicate effectively with management ... and deliver training to analysts, documenting training per procedural and cGMP requirements. + Support document revision, project, CAPA, and investigation/deviation… more
- ThermoFisher Scientific (Cambridge, MA)
- …Health and Safety to ensure safe operations at all times. Adhere to all customer cGMP SOP's Responsible for maintaining cGMP logs daily Maintain compliance with ... cGMP training Archiving GMP documents Raw material inventory and consumables stocking and control using SAP inventory systems **Position work hours:** Work hours are Monday-Friday 8-430pm. Weekend and holiday work is required on an as needed basis. **How… more
- Sanofi Group (Framingham, MA)
- …is responsible for providing Facilities, Engineering and Maintenance support for all cGMP process and utility systems at Framingham MA Campus, maintaining these ... issue resolution/leadership, corrective, preventive, and predictive/monitoring maintenance, audit readiness, cGMP compliance, capital investment recommendations, and adherence to established… more
- Bristol Myers Squibb (Devens, MA)
- …ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP . **Shifts Available:** 6pm - 6am, rotating scheduling including holidays ... of education and work experience is considered. + 2+ years of relevant cGMP experience with 1+ year of manufacturing site experience. + Experience in FDA/EMA… more
- ThermoFisher Scientific (Plainville, MA)
- …closely with colleagues to carry out manufacturing operations in alignment with cGMP standards. You will receive training in various departments, guaranteeing the ... Diploma or equivalent experience is the minimum requirement + Proven knowledge of cGMP + Ability to grow in a fast-paced, multidimensional environment with multiple… more
- Bristol Myers Squibb (Devens, MA)
- …responsible for leading and supporting deviation investigations within a cGMP -compliant cell therapy manufacturing environment. This role ensures timely, thorough, ... accurate and timely documentation of investigation activities in compliance with cGMP and internal procedures. + Coordinate with Manufacturing, Quality Assurance,… more
- ManpowerGroup (Walpole, MA)
- …Conduct inspection rounds to ensure utilities and equipment operate according to cGMP guidelines. + Manage small projects, coordinating with vendors and stakeholders ... NCs, and CAPAs. **What's Needed?** + 2-4 years of experience in cGMP and FDA-regulated facilities. + Working knowledge of Building Automation Systems (BMS),… more
- Bristol Myers Squibb (Devens, MA)
- …**Key Responsibilities:** + Follows and complies with all EHS guidelines, cGMP regulations, company policies and other external agency regulations, without ... Automation groups, in a Paperless work environment, following SOPs in a cGMP facility. + Assists in qualification activities related to instrumentation and… more
- Bristol Myers Squibb (Devens, MA)
- …works with Management to resolve. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy manufacturing ... thinking skills. **Basic Requirements:** + 4+ years of experience in cGMP bioprocessing manufacturing, cell therapy manufacturing or relevant experience + Bachelors… more
- Bristol Myers Squibb (Devens, MA)
- …improvement, and eliminate waste + Ensuring safe and compliant cGMP operations and maintaining permanent inspection readiness; Actively supporting regulatory ... therapy, biologics, or vaccine manufacturing/support desired + Proficient in cGMP 's and multi-national biopharmaceutical/cell therapy regulations + Excellent verbal/written… more