- Cardinal Health (Boston, MA)
- …pharmaceutical products, ensuring compliance with current Good Manufacturing Practices ( cGMP ) and relevant regulatory guidelines. This role demands a strong ... oversee the stability program and related studies, ensuring alignment with cGMP requirements and industry best practices. + **Repackaged Product Stability:** Manage… more
- Bristol Myers Squibb (Devens, MA)
- …ensure compliance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP . The Manager, Shop Floor Quality Assurance, Cell Therapy is responsible ... accordance with Bristol-Myers Squibb policies, standards, procedures, and Global cGMP . Functional responsibilities include ensuring operational compliance with applicable… more
- Bristol Myers Squibb (Devens, MA)
- …the patients by compliance with company procedures and policies, and cGMP requirements. + Efficiently coordinate, communicate, and provide Operations project ... technically sound, promote effective and efficient operations, and comply with cGMP requirements + Hire, mentor and develop exceptional people: Conduct performance… more
- Astellas Pharma (Westborough, MA)
- …(GMP) will assist in maintaining and facilitating all aspects of cGMP training, along with ensuring compliance with applicable regulations through appropriate ... MS with 0+ years of experience working in a CGMP environment BA/BS or equivalent. + Experience with developing...Good Laboratory Practice (GLP) and current Good Manufacturing Practice ( cGMP ) regulations, FDA Guidance, and ICH Guidance. + Ability… more
- Catalent Pharma Solutions (Chelsea, MA)
- …dryers include best-in-class GEA Niro SD1, SD4 and SD7, the latter being the largest CGMP unit of its kind for DPI in North America. Catalent Pharma Solutions is ... investigations to determine root causes of OOTs and/or OOSs according to cGMP standards required; + Demonstrated experience with analytical method development and… more
- Bristol Myers Squibb (Devens, MA)
- …are technically sound, promote effective and efficient operations, and comply with cGMP requirements. + Training others on SOPs, Work Instructions to successfully ... meet global Health Authority requirements. **Knowledge and Skills:** + Knowledge of cGMP regulations and FDA guidance applicable to biologics and cell therapy… more
- Curia (Hopkinton, MA)
- …any claims to be made in the investigation. This position primarily works in the cGMP production areas to manage adherence to the quality system and to initiate and ... patients' lives. Responsibilities + Maintain Quality databases and scanning of cGMP documents and records, Departures, media fill programs, and training files… more
- Sanofi Group (Framingham, MA)
- …clean utility systems that support manufacturing in a highly regulated cGMP environment.** **Clean Utilities Maintenance Technician** **The Clean Utilities ... execute maintenance activities.** **Document maintenance activities in compliance with cGMP requirements, including work orders, PMs, and calibration/verification records.**… more
- ThermoFisher Scientific (Plainville, MA)
- …grade biopharmaceuticals, qualification/validation of analytical methods for support of cGMP manufacturing, and the transfer and validation of assay methods ... from clients and/or Assay Development & Analytics to the cGMP QC testing laboratory. The manager ensures cGMP... cGMP QC testing laboratory. The manager ensures cGMP compliance, operates within budgets, and supervises bioanalytical lab… more
- Nitto Denko Corp. (Milford, MA)
- …of assigned production operations working within defined production schedules in a cGMP environment. Key Responsibilities: + May specialize in either purification or ... May act as a lead for any given campaign. + Review of basic cGMP documentation including solution and raw material reconciliation. + Develop, review and revise SOPs… more