- AECOM (Abilene, TX)
- …Estimates shall be provided in UNIFORMAT II and CSI format. + Undertake GMP finalization exercise following the completion of GC bid process. This includes ... meeting. These processes include but are not limited to GMP buyout review process, cost related document control, invoice...to the actual work carried out identifying any final GMP savings. + Work with GC and construction management… more
- PCI Pharma Services (Bedford, NH)
- …training metrics, and mentoring QA Training personnel to support compliance with GMP and regulatory requirements. The QA Training Supervisor plays a critical role ... and maintain comprehensive training programs to ensure compliance with GMP , FDA (21 CFR Parts 210, 211, & 820),...program, ensuring new employees receive the necessary training for GMP compliance and company policies. + Develop and maintain… more
- Actalent (St. Louis, MO)
- …supporting the site's QC sampling operations. This role involves the pickup of GMP manufacturing samples and their transport to various storage locations within QC. ... sub-aliquoting bulk samples into smaller aliquots as dictated by GMP documents and using the site's LIMS systems to...LIMS systems to generate sample print labels and record GMP transactions. The team collaborates closely with the QC… more
- Actalent (New Albany, OH)
- …Work Instructions. Responsibilities + Ensure regular presence in the packaging area to oversee GMP operations and quality systems. + Act as a first point of contact ... assist in sampling and inspections as required, and manage GMP documentation in support of daily operations. + Own,...Health and Safety goals. Essential Skills + Proficiency in GMP and Quality Assurance. + Experience in GMP… more
- Merck (Durham, NC)
- …maintenance activities are carried out in accordance with established safety, GMP , and calibration/maintenance procedures. + Assist in the identification and ... Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations **Preferred Experience and Skills:** + Associate Degree… more
- Merck (Jackson, MS)
- …are seeking a dynamic and experienced Quality & Compliance Director to lead GMP compliance across our global network of internal and external contract manufacturing ... (APIs) and finished products, including biologics and vaccines. As a trusted GMP compliance expert, you will drive regulatory excellence, support health authority… more
- Abeona (Cleveland, OH)
- …the Enterprise Quality Management System (EQMS), to support Good Manufacturing Practices ( GMP ) compliance at the Abeona Therapeutics Inc. site in Cleveland, OH. This ... out-of-specification (OOS) results, CAPAs, and Change Controls within a GMP -regulated cell and gene therapy manufacturing environment. The ideal candidate… more
- Hovione (East Windsor, NJ)
- …individually generated and ensure it is in accordance with all applicable GMP requirements and HSE regulations, adhering to all relevant Operating Procedures and ... notebooks in which he/she is involved to an acceptable GMP standard and in accordance with Hovione internal procedures....facility activities are carried out in compliance with all GMP , legal and HSE regulations and applicable standards in… more
- Actalent (Columbus, OH)
- …development team to transition existing cell-based therapy laboratory methods to the GMP production facility. The Technician will be required to master common ... others. The Technician will work in collaboration with the GMP Development Manager and staff and will use these...methods into closed system, high-throughput, scale-able processes for the GMP production facility. Works in collaboration with GMP… more
- Lilly (Lebanon, IN)
- …and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant ... collaboration, creativity and resilience as the site grows to a full scale GMP manufacturing through start up. Key Responsibilities: + Responsible for oversight of… more