- Lilly (Concord, NC)
- …a dynamic manufacturing environment. **Key Responsibilities** + Promote a safety-first, quality -always culture in all tasks and interactions + Improve equipment ... support production needs + Adhere to all GMP and quality standards + Must have the ability to quickly...a related field is a plus + Knowledge of FDA and GMP regulations + Experience operating high-speed, automated… more
- ThermoFisher Scientific (Greenville, NC)
- …the technical representative on client projects and collaborate with analytical, quality , and project management teams to drive successful process development, ... + Identify and document deviations from standard operating procedures (SOPs), quality standards, or regulatory guidelines. + Conduct product investigations and… more
- Fujifilm (Holly Springs, NC)
- …reports * Liaises with Contract Laboratory Organizations (CLOs), QC testing teams, Quality Assurance (QA), and Process Science groups to ensure prioritization of ... * Ensures compendial method oversight and scientific guidelines (eg ICH, EMA, FDA , etc.) * Supports regulatory requests and inspections * Supports the QC… more
- ThermoFisher Scientific (Greenville, NC)
- …digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities ... not limited to PV operations, training development, business objectives, quality initiatives and management, process improvement, compliance, and innovation. Applies… more
- Lilly (Concord, NC)
- …This individual must ensure cross functional collaboration between operations, engineering, quality , supply chain and maintenance to meet key metrics and ... leadership on manufacturing floor ensuring high level of safety, quality , and productivity to maintain reliable supply of products...of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and OSHA, or other similar groups… more
- Charles River Laboratories (Raleigh, NC)
- …or defective parts and pieces. + Inspect completed mechanical repairs for quality , safety, and proper operation. + Perform equipment calibration and preventative ... leader in the production and distribution of the highest quality research animal, with 1 out of 2 animal...development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …by following standard operating procedures and batch records in accordance with FDA current Good Manufacturing Practices. In addition, personnel in this position ... batch records and production of material promptly and with the highest quality standards. - Maintain documentation and functional work areas to CGMP standards.… more
- Charles River Laboratories (Raleigh, NC)
- …condition. As the world's leader in the production and distribution of the highest quality research animal, with 1 out of 2 animal models produced for preclinical ... we are passionate about our role in improving the quality of people's lives. Our mission, our excellent science...drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to… more
- ThermoFisher Scientific (Greenville, NC)
- …to the operations activities in the assigned. Supervises operations employees of high- quality pharmaceutical products according to schedules, cost, and quality ... collaborating with employees to ensure that every product unit is of high quality and exceeds all current Good Manufacturing Practices (cGMPs). . Ensures that… more
- Burns & McDonnell (Charlotte, NC)
- …effective management of change orders. + Applies knowledge and understanding of FDA , cGMP, and other concepts, practices, codes, and procedures within the industry. ... experience to complex projects, and find's/develops non-standard design solutions. + Quality review production drawings for a variety of projects and project-related… more