- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …test results. * Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements are followed. Duties include: Under the ... the Quality Associate role in a proficient manner. Has a basic understanding of cGMP and quality systems. Is able to spend hours sitting and reviewing documentation… more
- Fujifilm (Holly Springs, NC)
- …for operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility * Ensures project and operational quality objectives are ... 3+ years of experience in a GMP environment * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. * High… more
- Lilly (Concord, NC)
- …Responsible for shop floor execution as it relates to business plan, cGMP conformance, and Operational Standards for Manufacturing Excellence. + Striving and ... + 4+ years manufacturing/operations with 2+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + STEM… more
- Fujifilm (Holly Springs, NC)
- …operational readiness objectives and QA support of manufacturing operations in cGMP regulated facility * Participate in streamlining or efficiency improvement ... 1-3 years' experience in a GMP environment * Experience in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility… more
- Merck (Durham, NC)
- …requests within a current Good Manufacturing Practices ( cGMP ) context Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current ... **Required Skills:** Accountability, Adaptability, Analytical Problem Solving, Applied Engineering, cGMP Compliance, Data Analysis, Decision Making, Inventory Management, Lean… more
- BD (Becton, Dickinson and Company) (Mebane, NC)
- …a more senior level engineer + ISO compliance, FDA 21 CFR 820 compliance, and cGMP efforts - Understands and has knowledge of FDA and ISO regulations and cGMP ... . Requires oversight from SME to ensure compliance in all applicable areas + Computer Aided Design work - Functional with Solidworks and AutoCad. Ability to effectively create models, assemblies, and drawings with some guidance from SME. + Geometric… more
- Merck (Wilson, NC)
- …operations are performed in accordance with current Good Manufacturing Practices ( cGMP ), site Standard Operating Procedures (SOPs) and Divisional policies and ... within a vaccine, pharmaceutical, or GMP regulated environment + Experience within cGMP , FDA, regulated industry experience highly preferred + Packaging & Filling… more
- Fujifilm (Holly Springs, NC)
- …assays * General laboratory support and laboratory maintenance in a cGMP laboratory including maintaining laboratory supplies needed for operations, maintenance of ... MicroSeq) * Intermediate LIMS training * Knowledge or training of FDA regulations ( cGMP , cGLP, cGDP) * Trackwise System training * Lean / 6S training **Physical… more
- Fujifilm (Raleigh, NC)
- …lead/ and Head of site PM as required. + Compliance: Keep current on cGMP , regulatory and quality requirements that impact Company manufacturing. + All other job ... + Mastery knowledge in Project/Program Management. + Mastery knowledge of cGMP manufacturing operations and strong understanding of global manufacturing processes. +… more
- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …Clinical Laboratory Improvement Amendments (CLIA), Current Good Manufacturing Practice ( cGMP ) and internal company procedures. + Supervises donor selection, plasma ... regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and cGMP . + Attends all required training sessions, staff meetings, etc. + Ensures… more