- Catalent Pharma Solutions (Greenville, NC)
- …logistics. The Sample Management Specialist I follows all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the ... job function. Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …techniques, bioreactor operations, and cell line development + Strong knowledge of cGMP regulations and ICH guidelines relevant to upstream biologics manufacturing + ... Experience with a variety of expression systems (eg, CHO, HEK293, microbial) + Familiarity with Quality by Design (QbD) principles and their application to upstream processes + Excellent leadership skills with the ability to mentor and develop team members +… more
- ThermoFisher Scientific (Greenville, NC)
- …in a leadership function + Previous experience in pharmaceutical industry or cGMP environment required, preferably in aseptic or sterile processes. + An equivalent ... combination of education and relevant experience may be considered. **Knowledge, Skills, Abilities:** + Ability to make decisions while taking into account level of risks in regard to compliance and product quality. + Ability to gather data, analyze &… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …filtration, and potentially formulation/fill-finish operations. + Experience with cGMP manufacturing environments and regulatory requirements (FDA, EMA, ICH). ... + Familiarity with process validation principles and CPV. + Strong analytical, problem-solving, and data interpretation skills (statistical analysis knowledge is a plus). + Excellent communication, collaboration, and influencing skills. + Ability to work… more
- ThermoFisher Scientific (Greenville, NC)
- …5+ years supervisory experience. + Project Management skills desired. + Superior cGMP experience and leadership required. + Deep knowledge of cGMPs and ... pharmaceutical contract manufacturing, Quality Assurance, Compliance, Quality Control and Regulatory Affairs. + Advanced problem-solving skills and comfortable working directly with our valued customers to identify solutions. + Strong communication,… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …site Quality and/or efficiency. + Assess changes in terms of their impact to CGMP and using Risk Management tools. + Prepares and compiles the required data to ... support the APR submission for the products manufactured on site. + Provide support to collect and prepare QMR board presentation and associated documentation. + Ensure Quality Systems are compliant with CGMPs and internal/external regulations and procedures.… more
- Ingersoll Rand (Lillington, NC)
- …eliminating any errors and to work according to Current Good Manufacturing Practices ( cGMP ). + Monitor and maintain aseptic conditions in the filling room, including ... cleaning and disinfecting equipment and surfaces. + Follow all safety procedures and guidelines, including wearing appropriate personal protective equipment (PPE). + Complete all necessary documentation and records, including batch records and logbooks,… more
- Reckitt (Wilson, NC)
- …productivity. + Compliance & Documentation: Ensure all processes comply with cGMP , FDA, and Reckitt quality standards. Maintain accurate and complete documentation ... (batch records, SOPs, deviation reports). + Cross-Functional Collaboration: Work closely with Quality, R&D, Operations, and Supply Chain teams to ensure seamless operations and product launches. + Equipment & Technology: Evaluate and recommend new equipment or… more
- Lilly (Durham, NC)
- …Objectives/Deliverables:** + Lead a team of experienced Quality Engineers in providing cGMP and Lilly Global Quality Standard expertise working with Global Facility ... Delivery team, site engineering team, Lilly site staff, and selected A&E firm to support the verification and qualification of site facilities, utilities, and equipment, employing QbD and QRM principals and ensuring the integration of Global Quality System… more
- Lilly (Concord, NC)
- …+ 3+ years in manufacturing/operations with 2+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + Aseptic filling, ... single use assemblies, isolator technology. + Automated, semi-automated, and/or manual inspection. + Highly automated equipment (inspection, packaging, filling, assembly, etc.) + Creation of standard operating procedures, work instructions, and training… more