- Solstice Advanced Materials (Buffalo, NY)
- …value to our customers every day. As a Quality Assurance expert for a new cGMP manufacturing team. Ensure that appropriate cGMP Quality Systems are in place ... operating procedures impacting the safety, identity, strength, quality or purity of the cGMP products manufactured at the site. Conduct routine audits of 3 rd party… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …activities, and will be hands-on solving issues following technology transfer and cGMP start-up. The MSAT team establishes best practices for technical support of ... cGMP drug product manufacturing operations. The DP MSAT Engineer...transfer, manufacturing document creation, etc. + Reviews and approves cGMP batch documentation (eg master batch records, component specifications,… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …raw material manufacturers and distributers. The role supports and maintains all cGMP compliance aspects of Global Procurement operations under the direction and ... may include** + Supports and proactively maintains all Sourcing cGMP procedures, documentation and training related to SOP and...and reports CAPA to support audit closure. + Executes cGMP compliance documents and supports cGMP activities… more
- Regeneron Pharmaceuticals (Rensselaer, NY)
- …activities, and will be hands-on solving issues during technology transfer and cGMP start-up. They're also responsible for ensuring site to site consistency after ... actions. + Authors or reviews technical reports and protocols in support of cGMP activities. + Tracks and reports project achievements. + Establishes an internal and… more
- Regeneron Pharmaceuticals (East Greenbush, NY)
- …with quality compliance groups, strategically meet goals and lead External Manufacturing cGMP Policies and SOPs + Leads and prioritizes operations and practices for ... Regeneron audits + Provides expertise to the global External Manufacturing organization on cGMP compliance standard processes, as well as, new and developing cGMP… more
- Aerotek (Brookhaven, NY)
- …hour) **Description** Operate and monitor manufacturing equipment in compliance with cGMP standards. Follow Standard Operating Procedures (SOPs) to ensure consistent ... of equipment as needed. **Skills** Set up machine, Mixing, Blending, Cgmp , Pharmaceutical manufacturing, Compression molding, Machine operation, Change over **Top… more
- Actalent (Colonie, NY)
- …strict aseptic technique and compliance with current Good Manufacturing Practices ( cGMP ), USP / standards, and facility SOPsjobtarget.com. Ensure all activities meet ... of compliance and to mentor staff on best practices. Skills Pharmd, cgmp , 503b, pharmacist, sterile compounding, pharmaceutical Top Skills Details Pharmd, cgmp… more
- Lotte Biologics USA LLC (Syracuse, NY)
- …strong business acumen, and hands-on leadership in technical transfer, cGMP operations, and stakeholder management. Duties & Responsibilities Leadership & ... years of experience in the CDMO industry, with a strong background leading complex cGMP or technical transfer projects. + At least 5 years of project management… more
- BioLife Plasma Services (Latham, NY)
- …manufacturing is performed consistently according to current Good Manufacturing Practices ( cGMP ), the Shire Quality System, and other applicable regulations for a ... must also maintain complete and accurate records, in accordance with cGMP . ACCOUNTABILITIES Regulatory Compliance: (15%) Stays current with federal, state, local… more
- Catalent Pharma Solutions (New York, NY)
- …development, commercial operations + 5+ years of direct operational experience in cGMP manufacturing of cell-based therapies or experience in supporting customers in ... the cGMP space. + Expertise in cGMP ecosystem support functions (process development, analytical assay development and MS&T) is a plus. + Extensive customer… more
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