- Lilly (Durham, NC)
- …site facilities, utilities, and equipment. The position is essential for ensuring GMP compliance in the design, delivery, verification, qualification, start up, and ... life cycle maintenance of site assets, utilities and processes, maintain external linkages and support preparation for pre-approval and general inspections by regulatory agencies. **Key Objectives/Deliverables:** + Lead a team of experienced Quality Engineers… more
- Prestage (St. Pauls, NC)
- …production or supervisor needs require. Ensure USDA regulatory compliance, HACCP, SSOP, SOP, GMP , and SQF program quality, and safety. Advocate and maintain a strong ... commitment to safety in the operating process including but not limited to: PPE, preventing and reporting unsafe acts and conditions, Lockout-Tag out procedures, and Process Safety Management related matters. Requirements Education and/or Experience No prior… more
- Gilead Sciences, Inc. (Raleigh, NC)
- …+ Ensure all SAP PP/QM solutions comply with relevant regulatory requirements, including GMP , FDA 21 CFR Part 11, and other applicable standards. + Partner with ... Validation teams to develop and maintain validation documentation, including validation plans, test scripts, and traceability matrices. **Inspiring Team Leadership & Mentorship:** + Build and lead a high-performing team of SAP professionals, providing clear… more
- ThermoFisher Scientific (Asheville, NC)
- …40 lbs. without assistance, Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal ... Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Standing for full shift, Strong Odors (chemical, lubricants, biological products etc.), Various outside weather conditions **Job Description** **Position Summary** At… more
- Dairy Farmers of America (Winston Salem, NC)
- …regarding health and safety issues . Follow all DFA good manufacturing practices ( GMP ) and work in a manner consistent with all corporate regulatory, food safety, ... quality, and sanitation requirements . The requirements herein are intended to describe the general nature and level of work performed by employee, but is not a complete list of responsibilities, duties, and skills required. Other duties may be assigned as… more
- Coty (Sanford, NC)
- …in critical KPI's for the manufacturing facility._ + _Follow all site GMP policies and procedures._ + _Other duties as assigned._ **QUALIFICATIONS** We'd love ... to see candidates who have: **Knowledge:** + _Analytical problem solving and information gathering skills (Key Performance Indicator reporting, gap analysis, Kaizen, Loss Tree, cause-and-effect diagrams, 5-whys, etc.)_ **Functional / Technical Skills:** +… more
- Fujifilm (Holly Springs, NC)
- …equivalence + Experience in manufacturing of biological products, familiar with GMP /GLP requirements + Previous experience leading, supervising or managing others ... **PHYSICAL REQUIREMENTS** **_PHYSICAL DEMANDS_** + Will work in an environment which may necessitate respiratory protection + May work in Mechanical/Production spaces that may require hearing protection and enrollment in a hearting conservation program +… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …specific batch records. - Maintain documentation and functional work areas to GMP standards. - Communicates effectively to area leadership and all cross functional ... groups to ensure completion of production demands. - Communicates effectively to area leadership and all cross functional groups to ensure completion of production demands. - Assesses situation and provides accurate recommendations to overcome challenges,… more
- Fujifilm (Holly Springs, NC)
- …batch disposition * 4+ years of experience working in a GMP environment **Preferred Requirements** * Previous experience with Smartsheet, Trackwise, MasterControl, ... Veeva and/or Kneat validation software * Previous experience of one or more of the following processes o cell culture/upstream processes o large scale recovery/downstream processes o aseptic processing * Experience with complex projects to keep work pace and… more
- ThermoFisher Scientific (High Point, NC)
- …hr shift/nights **Environmental Conditions** Adherence to all Good Manufacturing Practices ( GMP ) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail ... polish, perfume, exposed piercings, facial hair etc allowed, Loud Noises (Equipment/Machinery), Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.) **Job Description** As part of the Thermo… more