- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …and batch records in accordance with FDA current Good Manufacturing practices ( cGMP ). In addition, personnel in this position will support the production operation ... than perfection + Thinks creatively with the bounds of cGMP framework to overcome challenges and brings viable solutions...good manual dexterity. + Must possess basic knowledge of cGMP -s. + Must be able to transcribe detailed data… more
- Fujifilm (Holly Springs, NC)
- …Drug Product Manufacturing including training of new colleagues. Maintains compliance of cGMP documents and to assist in qualification of equipment and all aspects ... (pH, conductivity, visual inspection) * Executes validation protocols according to cGMP Standard Operating Procedures (SOPs) * Maintains training to perform all… 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
- Amgen (Holly Springs, NC)
- …in our upstream area and are responsible for the manufacturing of cGMP (Current Good Manufacturing Practices) drug substance. With general direction, the Associate ... will support all floor operations in accordance with cGMP practices. Compliance: + Completes work in accordance with established cGMP procedures and policies… more
- Cambrex High Point (Durham, NC)
- …and stability monitoring of bulk drug substances and drug products under cGMP guidelines + Independently develop and evaluate methodologies, design and implement ... of project tasks and deliverables + Responsible for ensuring compliance with cGMP and other regulatory guidelines. + Analyze information for technical correctness… more
- Cambrex High Point (Durham, NC)
- …and stability monitoring of bulk drug substances and drug products under cGMP guidelines + Independently develop and evaluate methodologies, design and implement ... of project tasks and deliverables + Responsible for ensuring compliance with cGMP and other regulatory guidelines. + Analyze information for technical correctness… 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
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …(-DIO-) is responsible for ensuring the accuracy and reliability of cGMP data and data supporting regulatory submissions. Generally, this requires implementing, ... and implementation of software used for the generation of cGMP data + Conduct audits and gap assessments based...and implementation of software used for the generation of cGMP data + Assess training program and materials for… more
- Biomat USA, Inc. (Research Triangle Park, NC)
- …out of our RTP, NC Office.** Ensures current Good Manufacturing Practices ( cGMP ) and FDA/Grifols Quality Systems are adhered to throughout the evaluation, review ... and quality assurance/control documentation. + Assists in the development of cGMP operating procedures that relate to process, computer systems, and equipment… more
- Fujifilm (Holly Springs, NC)
- …of the Drug product filling line + Execute validation protocols according to cGMP Standard Operating Procedures (SOPs) + Own the establishment of processes and ... Degree + 4 years of direct experience in a cGMP manufacturing environment **OR** + BA/BS + 2 years...BA/BS + 2 years of direct experience in a cGMP manufacturing environment + Equivalent Military training or experience… more