- Fujifilm (Holly Springs, NC)
- …Associate 2 executes and documents manufacturing processing activities per cGMP environment.. This manufacturing facility is 24/7operational and the role ... (pH, conductivity, visual inspection) * Executes validation protocols according to cGMP Standard Operating Procedures (SOPs) * Maintains training to perform all… more
- West Pharmaceutical Services (Kinston, NC)
- …rooms such as pre-staging, staging, loading, unloading and final packaging, per cGMP standards. + Strict adherence to product/customer specifications. + Ensure that ... calibration. + Correctly sample product for QA inspections and pre-delivery samples in cGMP manner. + Keep equipment and work area in clean and orderly condition.… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …the highest quality standards. - Maintain documentation and functional work areas to CGMP standards. - Capable of lifting and moving heavy equipment parts and ... good manual dexterity. - Must possess basic knowledge of CGMP -s. - Must be able to transcribe detailed data...be able to transcribe detailed data accurately according to CGMP and SOP standards. - Must be able to… more
- Fujifilm (Holly Springs, NC)
- …Practices (GMP) regulations. You will maintain quality systems that align with CGMP , GDP, and other regulatory standards, ensuring product compliance through robust ... requests as necessary + Establishes robust QA processes to ensure adherence to cGMP regulations and alignment with client Quality Agreements + Assesses the impact of… more
- Actalent (Winston Salem, NC)
- …operations, focusing on cell processing activities and ensuring compliance with cGMP guidelines. This role involves operating and maintaining production equipment ... + Lead and oversee cell processing activities, ensuring compliance with cGMP guidelines and manufacturing standards. + Read, understand, and implement Standard… more
- Merck (Durham, NC)
- …of working with a focus on safety, current Good Manufacturing Practices ( cGMP ) compliance and efficiency. + Define requirements and specifications for equipment. + ... **Hazardous Material(s):** n/a **Required Skills:** Applied Engineering, Applied Engineering, cGMP Compliance, cGMP Regulations, Computerized Maintenance Management… more
- ThermoFisher Scientific (Greenville, NC)
- …and manufacturing. This colleague follows written and verbal instructions using cGMP documents and operating equipment when performing the following duties. **Shift ... are manufactured in accordance with area SOPs and current cGMP . + Verify and document production activities in batch...products in an aseptic filling area, including: + Cleaning cGMP Areas + Parts Preparation + Filter Integrity Testing… more
- J&J Family of Companies (Wilson, NC)
- …11, GAMP and 21 CFR Part 11 **Key Responsibilities:** + Review and approve cGMP automation documents including: DeltaV, PAS-X MES and OSI PI software FAT and SAT ... and Software Installation Verification protocols. + Review and approve non- cGMP automation documents including Honeywell BAS software, FAT and SAT… more
- Pfizer (Sanford, NC)
- …actions. + Adhere to all company and Good Manufacturing Practices ( cGMP ) procedures, safety regulations, and participate in the development of validation ... standards. + Work effectively as a member of the Quality Operations (QO) cGMP training team, collaborating with Business Area Training Leads, Coordinators, and SMEs… more
- Biomat USA, Inc. (Greenville, NC)
- …Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice ( cGMP ). + Accountable for donor selection, plasma collection and all ... Clinical Laboratory Improvement Amendments (CLIA), and Current Good Manufacturing Practice ( cGMP ). + Directs through the management team and with Training and… more