- Catalent Pharma Solutions (Kansas City, MO)
- **Division:** PCH-EP **Location:** Kansas City **I. Position Overview:** The Team Lead , GMP Storage role is responsible for overseeing daily operations of GMP ... while leading a team to safely manage, safeguard, and accurately track all GMP materials from receipt through finished goods completion. Serves as Subject Matter… more
- United Therapeutics (Research Triangle Park, NC)
- …while supporting both existing and oncoming sites. **How you'll contribute** The Lead CMMS Specialist, GMP , provides advanced Blue Mountain Regulatory Asset ... Manager (BM-RAM) and documentation support across multiple GMP -regulated UT sites. This role performs day-to-day CMMS updates, maintains high-quality equipment and… more
- Actalent (Winston Salem, NC)
- …Revise, update, and ensure adherence to SOPs, batch records, and MS forms, maintaining GMP compliance. + Lead routine cycle counts and ensure accurate inventory ... and ensuring high levels of quality and compliance. Responsibilities + Lead and oversee cell processing activities, ensuring compliance with cGMP guidelines… more
- Merck (Durham, NC)
- **Job Description** The Quality Associate Director/ GMP Lead Site Auditor will have leadership responsibility for the site internal audit program, encompassing ... achieve excellence and ensure program is effective. The position requires ability to lead and perform the operational aspects of the audit program, apply risk-based… more
- Merck (Rahway, NJ)
- …knowledge & leading efforts in Operational Readiness to deliver and stand up a new GMP clinical facility. + Lead a team engaged in both day-to-day production ... both in terms of facility construction and organizational realization. The GMP facility is designed for multi-product operations with flexible operating suites,… more
- Price Chopper (Schenectady, NY)
- …spare parts, and tools. + Communicate effectively to maintain building safety and GMP compliance. + Lead hiring, training, and development of Team Members. ... improvement in a food manufacturing environment. **ESSENTIAL DUTIES AND RESPONSIBILITIES** + Lead and inspire the daily operations of the maintenance team by… more
- Kelly Services (Petersburg, VA)
- …for the process safety activities associated with technology transfer, process design, and GMP startup (4) Lead process safety assessments, Management of Change ... (MOC), and the implementation and verification of safeguards in GMP manufacturing (5) Lead PFMEAs, PHAs, and PSSRs for new and existing API processes; translate… more
- UL, LLC (Allentown, PA)
- Lead Auditor - GMP Quality Audits will perform high level assessments of quality systems in a variety of manufacturing sites, farms, processing plants and/or ... conditions as it relates to established industry standard(s) for GMP , Quality Systems, Food Safety initiatives and/or client programs....play an active mentoring role with trainees, auditors and lead auditors in the field. + Participate and … more
- Genentech (Holly Springs, NC)
- …SAP upgrade & LIMS replacement). + Accountable for MES Support team in a 24/7 GMP Manufacturing environment + Lead teams/ Provide 24/7 on call support for ... execution systems for process, utility and building systems as appropriate. Lead MES impacting projects with large and/or complex scope. Drive strategic… more
- Insight Global (East Whiteland, PA)
- …Key Responsibilities: - NPI & Program Coordination: Support NPI tech transfers into GMP DS manufacturing. Lead kickoff, work‑cell, and core team meetings. Track ... Job Description The NPI Coordinator supports NPI activities in a GMP biologics Drug Substance facility by coordinating timelines, materials, documentation, and… more
- Cardinal Health (Indianapolis, IN)
- …Champion Quality, GMP compliance and EHS/Radiation Safety practices. + Develop and lead GMP /GDP training of all employees. Follows/ mentors GDP/ GMP ... outcomes. + Able to challenge, appropriately, the design, conduct, and reporting of GMP activities including metrics and annual reporting. In that context, has the… more
- Post Holdings Inc. (West Jefferson, OH)
- …while they are onsite to include human safety, food safety, and plant GMP requirements. + Lead department team members to ensurepersonal safety,quality, ... jobs and tasks. + Adheres toquality work practices, follows GMP 's,maintainssanitary conditions and ensures that product quality ismaintained. Reportsonany conditions… more
- Mentor Technical Group (Juncos, PR)
- …Puerto Rico, Dominican Republic, Mexico, Germany, Canada and South America. The GMP Cleaning and Sanitization Group Leader will assist the Supervisor in ensuring ... monthly inventories and ensuring minimum and maximum levels. + Lead a staff and communicate effectively, train and monitor...Ensure the team is following the cleanliness of the GMP facility in accordance with Cleaning and Sanitation SOPs… more
- Bristol Myers Squibb (Summit, NJ)
- …place than here at BMS with our Cell Therapy team. The Senior Manager, GMP Facilities provides leadership and direction to the 24/7 Facilities and Maintenance team ... Department. This team is responsible for ensuring that the Summit West GMP manufacturing facilities and supporting equipment are operated and maintained to ensure… more
- Otsuka America Pharmaceutical Inc. (Annapolis, MD)
- The Director, Global Product Quality, GMP Processes is a strategic leadership role responsible for **benchmarking, standardizing, and optimizing global quality ... product quality systems are aligned with **Good Manufacturing Practices ( GMP )** and regulatory requirements while driving **efficiency, consistency, and continuous… more
- Genentech (South San Francisco, CA)
- …is integral to the seamless functioning of both Good Manufacturing Practice ( GMP ) and non- GMP operations. As a Technical Lead , you will be a working lead ... **Key Responsibilities** **Operational Supervision:** + Act as a key support in GMP and non- GMP projects, ensuring smooth engineering operations. + Attend… more
- PCI Pharma Services (San Diego, CA)
- …responsibilities, evaluating performance and rewarding as appropriate. In addition the Group Lead will review GMP documents and participate in process ... investigations and deviations while ensuring GMP compliance and inspection-readiness. The Group Lead also assists middle and upper management in interviewing and… more
- Hovione (East Windsor, NJ)
- …commissioning and qualification , coordinating all testing and verification activities to ensure GMP compliance. + Support or lead the handover process of ... drawing on standards and past experiences to drive effective solutions. + Lead readiness activities for regulatory inspections and internal/client audits , by… more
- ThermoFisher Scientific (Middleton, WI)
- …(Days) **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Laboratory Setting, Office **Job Description** **Position** ... _This is a fully onsite role based at our GMP Laboratory in Middleton, WI. We welcome applicants from...assists with the study design & protocol authoring, and lead data evaluation and study close-out. **A Day in… more
- Takeda Pharmaceuticals (Lexington, MA)
- …provide strategic quality guidance internally and to CMOs/partners. + Support or lead continuous improvement initiatives that enhance R&D GMP Quality processes ... my knowledge. **Job Description** **About the role** The Principal Manager, R&D GMP Pharmaceutical Sciences Quality EU & US provides Quality oversight across… more