- Quality Chemical Laboratories (Wilmington, NC)
- …working independently from concept and product prototype through transfer to cGMP Manufacturing. The ideal candidate will possess strong problem solving abilities, ... development. Experience in process development and technology transfer into cGMP manufacturing, familiarity with analytical techniques, regulatory requirements, and… more
- Quality Chemical Laboratories (Wilmington, NC)
- …Chemical Laboratories (QCL) serves the biopharmaceutical industry. We provide expert and cGMP compliant scientific testing services in support of both small and ... large-molecule drug products, drug substances, in-process materials, and raw materials in all phases of Research, Development, and Commercialization. QCL provides formulation development and solid dose GMP manufacturing supporting early-phase clinical trials.… more
- University of Southern California (Los Angeles, CA)
- …what it is. USC's Keck School of Medicine, current Good Manufacturing Practices ( cGMP ) facility is seeking a dynamic individual to work on the process development ... and gene therapies and other biological products for internal/external users. The cGMP Process Development (PD) Specialized Lab Technician at the USC/CHLA cGMP… more
- University of Southern California (Los Angeles, CA)
- …of internal/external users in the university's current Good Manufacturing Practices ( cGMP ) facility. The Quality Control (QC) Specialist is responsible for ... be responsible for ensuring consistency with current Good Manufacturing Practice ( cGMP ) principles. Job Accountabilities: + Supports cGMP manufacturing… more
- University of Southern California (Los Angeles, CA)
- …staff that make the university what it is. USC's Keck School of Medicine, cGMP Department is seeking a dynamic individual to foster and enhance the translation and ... biological products for internal/external users. The Associate Director of Process Development ( cGMP ) is responsible for all aspects of operations related to the… more
- Catalent Pharma Solutions (Morrisville, NC)
- …raw material, in-process sample, stability, and finished product release to meet cGMP regulations and project timelines. They are also responsible for overseeing ... investigations with statistical analysis and risk assessment + Solid knowledge of cGMP , ICH, FDA, EMA regulations or guidelines **Why you should join Catalent:**… more
- University of Southern California (Los Angeles, CA)
- …therapy of internal/external users in the university's current Good Manufacturing Practices ( cGMP ) facility. The cGMP Quality Control (QC) Specialized Lab ... Technician is responsible for performing moderate to complex laboratory procedures such as cell expansion, harvesting, cryopreservation, media preparation, sterility testing, endotoxin assays, and mycoplasma detection, among others. Other key responsibilities… more
- 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
- Sanofi Group (Swiftwater, PA)
- …as the Quality head of the site with regards to product quality, safety and cGMP compliance as well. + Oversees the **QC activities** to guarantee that all products ... ensure that the products released strictly meet the requirements in both cGMP compliance of the manufacturing, testing, storage and distribution operations and… more
- Kelly Services (Pittsburgh, PA)
- …+ Maintains a solid understanding of the equipment used within the cGMP manufacturing process and utilizes that understanding within projects, risk assessments, ... Assurance). + Provides technical support for equipment associated with the cGMP manufacturing process, and provides feedback associated with internal and external… more
- West Pharmaceutical Services (Exton, PA)
- …to meet deliverables for commissioning integrated computer systems in a cGMP environment while reducing risk and improving compliance and productivity. **Essential ... for meeting the validation needs of regulatory bodies and cGMP laboratory + Support and/or be the liaison between...requirements (FDA, EU) for computer systems, new technologies and cGMP regulations + Comply with all safety practices and… more
- Cook Medical (Pittsburgh, PA)
- …* Maintains a solid understanding of the equipment used within the cGMP manufacturing process and utilizes that understanding within projects, risk assessments, ... Assurance). * Provides technical support for equipment associated with the cGMP manufacturing process, and provides feedback associated with internal and external… more
- Sanofi Group (Swiftwater, PA)
- …of the appropriate cold room logbooks in accordance with good cGMP documentation practices and follow departmental operating procedures are required. Technicians ... log book and Topp Clip form in accordance with cGMP documentation practices as pallets are moved from one...storage and warm room log book in accordance with cGMP documentation practices as pallets are moved from one… more
- Sanofi Group (Swiftwater, PA)
- …volume and needs + Completes tasks and corresponding documentation as required by cGMP to ensure document completion. + Works to prepare assigned areas for the ... level) as assigned. + Follows proper documentation as required by cGMP . + Has a thorough working knowledge of cGMP 's and works to help others understand. + In on… more
- Fujifilm (Research Triangle Park, NC)
- …activities while maintaining strict adherence to Current Good Manufacturing Practice ( CGMP ), quality and regulatory standards. Flexibility with working hours and ... right place for you. From our Bioprocess Innovation Center to our cGMP -compliant manufacturing site, we thrive on collaboration, creativity, and purpose. Whether… more
- Aerotek (Gaithersburg, MD)
- …and store materials in appropriate warehouse locations, including cold storage, following cGMP and safety protocols. + Pick, pack, prepare, and ship orders, ... including hazardous and biological materials, in compliance with cGMP and approved procedures. + Fulfill reservations to support CDMO operations efficiently. +… more
- Boehringer Ingelheim (St. Joseph, MO)
- …supporting production processes, and/or executing relevant functions in a cGMP manufacturing/operations environment or similar organization required. OR In lieu ... supporting production processes, and/or executing relevant functions in a cGMP manufacturing/operations environment or similar organization required. Experience must… more
- Actalent (Easton, MD)
- …providing support to ensure compliance with current Good Manufacturing Practice ( cGMP ) and internal procedures. The successful candidate will ensure overall ... including but not limited to, testing and methods in accordance with cGMP . Responsibilities + Inspect incoming components, in-process products, and finished products… more
- Actalent (Easton, MD)
- …providing support to ensure compliance with current Good Manufacturing Practice ( cGMP ) and internal procedures. The successful candidate will ensure overall ... compliance, including testing and methods in accordance with cGMP , and will inspect incoming components, in-process products, and finished products as per documented… more
- Genentech (Hillsboro, OR)
- …failures and equipment issues while adhering to strict guidelines on cGMP documentation. In addition the individual will support planned events/unplanned ... Control policies, procedures, specifications and testing methods consistent with cGMP , regulations, appropriate compendium, and Roche/Genentech standards, policies, plans,… more
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