- Legend Biotech USA, Inc. (Raritan, NJ)
- …of personalized cell therapy to support both clinical and commercial requirements in a sterile GMP environment. This role includes supervision of QA shop floor ... Product Development, and Quality/Manufacturing personnel.Independently makes appropriate and compliant GMP decisions.Independently resolves problems through the use of quality… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …therapy manufacturing facility to support both clinical and commercial requirements in a sterile GMP environment. This role will ensure compliance within the ... needed.Issue batch related documentation and labels in support of GMP manufacturing.Reconcile GMP documentation following document lifecycle requirements.Create… more
- Merck & Co. (Durham, NC)
- …troubleshooting and maintenance support to B160 Operations areas ( sterile supply, weigh/dispense, media, stabilizer/prep, Drug substance, filling, ... capping/inspection, clean utilities etc.) located in aseptic and clean room environments.- Works within a team to perform maintenance and troubleshooting… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …aseptic cleaning, equipment preparation for sterilization, product pathway assembly, sterile filtration, aseptic filling and terminal sterilization. + ... Sterile Injectable Supervisor Department: Production Location: Monroe, NC...Degree preferred Experience: 5 - 7 Years- experience in CGMP / Aseptic Operations Background Knowledge & Skills: +… more
- Endo International (Rochester, MI)
- …all equipment in the department for the purpose of cleaning and disinfecting/sanitizing/fogging aseptic and non- aseptic GMP areas + Maintains supplies and ... for sterile filling production waste. 30% Documentation + Documents GMP records, LUMAC logbooks and sanitation schedules, upon completion of daily work… more
- Catalent Pharma Solutions (Harmans, MD)
- …Contamination controls) + Highly experienced in Biopharmaceutical, pharmaceutical manufacturing and/or aseptic processing working in a GMP environment. + ... Sterility Assurance** will be responsible for quality assurance oversight of Aseptic Processing Program, Environmental Monitoring and Microbial Control Policies for… more
- Catalent Pharma Solutions (Baltimore, MD)
- …Standard Operating Procedures (SOPs), and Batch Production Records (BPRs) to manufacture sterile drug product in an aseptic , clean room environment. Complete ... **Associate III, Manufacturing** is responsible for supporting the overall GMP Fill Finish manufacturing processes, through the application of...maintenance and repair as necessary. + Work within an aseptic clean room in full sterile gowning.… more
- Actalent (Winston Salem, NC)
- …standards. Essential Skills + Aseptic technique + Cleanroom experience + Sterile processing + Cell culture + GMP compliance + Laboratory operations ... operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves operating and maintaining production equipment… more
- Fujifilm (Thousand Oaks, CA)
- …+ Direct experience is highly desirable in environmental monitoring, personnel monitoring, sterile gowning, and aseptic process control in accordance with ICH, ... supporting and maintaining QC microbiological functions for new and existing GMP manufacturing operations. This position will also support facility qualification… more
- Curia (Albuquerque, NM)
- …formulation and filling operations. Oversee processing operations (ENG and GMP ) including equipment preparation, bulk product formulation, sterile ... field + Minimum eight (8) years' experience in a cGMP /FDA, regulated environment + Experience with aseptic ...noise in the background. The pharmaceutical manufacturing environment is sterile . Therefore, aseptic gowning is required. Personal… more
- Unither Pharmaceuticals (Rochester, NY)
- …With 30 years of technological expertise, we position ourselves as a world leader in sterile single dose with 10 sites on 4 continents and more than 2000 employees. ... 280 employees. Your role Reporting to the Manufacturing Supervisor, The Aseptic Manufacturing Associate is responsible for manufacturing pharmaceutical batches by… more
- Fujifilm (Thousand Oaks, CA)
- …principles including global cGMP requirements + Working knowledge in the cGMP requirements pertaining to sterile drug product manufacturing operations in the ... what we call Genki.** The Specialist QA, Compliance supports the Cellular Therapy GMP quality program. This individual is responsible for the management of the… more
- Curia (Albuquerque, NM)
- …and vial sealing) of parenteral products according to Current Good Manufacturing Practice ( cGMP ) in an aseptic environment. This role will train, coach/develop, ... enhance production processes and efficiency. The position also involves sanitizing aseptic and controlled areas using specialized solutions and equipment, following… more
- Curia (Albuquerque, NM)
- …produce sterile quality products + Document information, events, and cGMP manufacturing processes, accurately and completely + Perform duties in an organized, ... conversational noise in the background. The pharmaceutical manufacturing environment is sterile . Therefore, aseptic gowning is required. Personal protective… more
- Curia (Albuquerque, NM)
- …produce sterile quality products + Document information, events, and cGMP manufacturing processes, accurately and completely + Perform duties in an organized, ... conversational noise in the background. The pharmaceutical manufacturing environment is sterile . Therefore, aseptic gowning is required. Personal protective… more
- Curia (Albuquerque, NM)
- …conversational noise in the background. The pharmaceutical manufacturing environment is sterile . Therefore, aseptic gowning is required. Personal protective ... platform + And more! Summary: The Director of Quality Operations oversees CGMP Quality Operations, including Incoming QA (IQA), Manufacturing QA (MQA), Aseptic… more
- Bristol Myers Squibb (Warren, NJ)
- …Endotoxin, Sterility testing and microbiology laboratory maintenance functions within the cGMP operation for CTDO Developmental QC for CAR T. Additional activities ... tracking and chain of custody records in accordance with GMP requirements and written procedures + Ensuring that obsolete...material team. + Ability to gown and maintain a sterile work environment. + Perform microbial isolation techniques and… more
- Catalent Pharma Solutions (Harmans, MD)
- …technology; + Familiarity with cGMPs, regulatory filings, and compliance issues for sterile injectable products manufactured by aseptic processing; + Application ... of quality and service. Catalent provides process development and GMP manufacturing services for Phase I/II clinical trials to...All work to be carried out in compliance with cGMP and company standard operating procedures and policies. **This… more
- Fujifilm (College Station, TX)
- …+ Experience with qualification/validation of process equipment, clean utilities, automation, sterile filling, aseptic processing, facilities, HVAC, and new ... functions to instill a 'Quality Culture' by coaching in the application of GMP Principles including the underlying rational of those principles. + Knowledge and… more
- Fujifilm (College Station, TX)
- …+ Experience with qualification/validation of process equipment, clean utilities, automation, sterile filling, aseptic processing, facilities, HVAC, and new ... a 'Quality Culture' by coaching in the application of GMP Principles including the underlying rational of those principles....4+ years of supervisory experience. + 4+ years of cGMP experience. + Single Use and Process Validation preferred.… more
