- Merck & Co. (Durham, NC)
- …all aspects of Quality oversight for drug substance, media preparation, and sterile supply. The candidate will have the opportunity to apply their enthusiasm ... assigned aspects of the project proceed in compliance with cGMP , regulations, and our Company's Quality Management System. Provide...shop floor support in the execution and review of GMP documentation such as IQ, OQ and other technical… 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 serve as the business process ... quality systems processes.Ensure compliance with current Good Manufacturing Practices ( cGMP ).Manage multiple and complex cross-functional projects with many stakeholders.Support… 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
- Curia (Albuquerque, NM)
- …and schedule adherence through expertise according to the current Good Manufacturing Process ( cGMP ) and aseptic processes. The Aseptic Core Monitor (ACM) ... GMP experience in an FDA-regulated pharmaceutical environment + Aseptic processing experience, including proficiency in aseptic gowning qualifications… 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 ... containers for sterile filling production waste. ▪ Documentation ▪ Documents GMP records, LUMAC logbooks and sanitation schedules, upon completion of daily work… 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 (Hanover, MD)
- …or Biotech field with 5-7 years in relevant discipline required (eg, cGMP Aseptic operations, Quality, Sterility Assurances, Contamination controls) + Highly ... experienced in Biopharmaceutical, pharmaceutical manufacturing and/or aseptic processing working in a GMP environment. + Demonstrate strong scientific… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …aseptic cleaning, equipment preparation for sterilization, product pathway assembly, sterile filtration, aseptic filling and terminal sterilization + ... Associate/Bachelor Degree preferred Experience: 3 - 5 Years- experience in CGMP / Aseptic Operations Background START YOUR APPLICATION… more
- Sanofi Group (Swiftwater, PA)
- …quality experience preferred in a GMP regulated environment + Accessing aseptic processing areas, sterile gowning, exceptional eye sight, sampling technique, ... bring hope to patients and their families. Ensure compliance with cGMP , regulatory, and internal requirements regarding the manufacturing, testing, and distributing… more
- Novo Nordisk (Bloomington, IN)
- …what matters. Primary - Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment preparation, product formulation, ... material staging, and aseptic filling. Product in this area is filled into...area is filled into vials, syringes, or cartridges inside sterile isolator barriers. The sterile barrier isolator… more
- Novo Nordisk (Bloomington, IN)
- …what matters. Primary - Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment preparation, product formulation, ... material staging, and aseptic filling. Product in this area is filled into...area is filled into vials, syringes, or cartridges inside sterile isolator barriers. The sterile barrier isolator… more
- Novo Nordisk (Bloomington, IN)
- …what matters. Primary - Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment preparation, product formulation, ... material staging, and aseptic filling. Product in this area is filled into...area is filled into vials, syringes, or cartridges inside sterile isolator barriers. The sterile barrier isolator… more
- Novo Nordisk (Bloomington, IN)
- …what matters. Primary - Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment preparation, product formulation, ... material staging, and aseptic filling. Product in this area is filled into...area is filled into vials, syringes, or cartridges inside sterile isolator barriers. The sterile barrier isolator… more
- Merck (Durham, NC)
- …all aspects of Quality oversight for drug substance, media preparation, and sterile supply. The candidate will have the opportunity to apply their enthusiasm ... assigned aspects of the project proceed in compliance with cGMP , regulations, and our Company's Quality Management System. +...shop floor support in the execution and review of GMP documentation such as IQ, OQ and other technical… 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
- Kelly Services (Parsippany, NJ)
- …Looking For:** + **3+ years** of engineering or compliance experience in a ** GMP -regulated facility** (preferably sterile or aseptic manufacturing). Degree ... **Quality Facilities Specialist- Compliance** **( GMP | Sterile Manufacturing | Deviation...root causes and corrective actions. + Ensure compliance with cGMP , FDA regulations, and internal SOPs. + Manage records… more
- Endo International (Rochester, MI)
- …that perform: 1) cleaning and sterilization of equipment and components for aseptic / sterile operations. Production includes a variety of drug and biological ... maintains cooperative cross-functional relationships with peers and leadership in Quality, Sterile Operations, Process Development, and Supply Chain to meet plant… 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. ... equipment. Executes all Production processes while strictly adhering to cGMP , Standard Operating Procedures, documentation protocols, environmental health and safety… 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
