- Owens & Minor (Morrisville, NC)
- …preventive maintenance on vehicles is performed on a timely basis according to DOT, FDA and Joint Commission. + Responds to emergency delivery calls as needed and on ... Training Program. + Must meet job-related requirements to comply with DOT, FDA and Joint Commissions regulations. **SKILLS, KNOWLEDGE AND ABILITIES** + Business… more
- ThermoFisher Scientific (Morrisville, NC)
- …and business priorities. + Conduct audits in alignment with relevant standards (eg, FDA , EMA, ICH, ISO). Site Engagement & Audit Logistics + Coordinate logistics for ... + Proficient knowledge of international quality and regulatory standards (such as FDA , EMA, ICH Q-series, ISO 13485). + Lead Auditor certification or equivalent… more
- Norstella (Raleigh, NC)
- …and biotech companies around the world, along with regulators like the FDA , and payers. By providing critical proprietary data supporting AI-driven workflows, ... Norstella helps clients make decisions faster and with greater confidence. Norstella's investments in AI are transforming how data is consumed and decisions are made, disrupting inefficient legacy workflows and helping the industry become more efficient,… more
- ThermoFisher Scientific (Greenville, NC)
- …ability to learn the company's SOPs, WPDs, and relevant regulations (eg ICH/GCP, FDA guidelines) + Strong organizational and negotiation skills + Strong attention to ... detail + Advanced written and oral communication skills + Strong knowledge of English language and grammar + Demonstrated use of computer to include data entry, archival and retrieval + Ability to travel as needed + Excellent team player with team building… more
- Catalent Pharma Solutions (Greenville, NC)
- …all work is accurate, precise, properly documented, compliant with SOPs and FDA cGMP guidelines + With supervision, document batch manufacturing in batch records ... accurately and completely as required + Perform and witness manufacturing steps + Perform, document, and witness breakdown and cleaning of process equipment, including storage. Ensure communication with CV group and Scientific Staff. **The Candidate** + High… more
- Catalent Pharma Solutions (Greenville, NC)
- …documented in equipment and room logbooks, accurately and compliant with SOPs and FDA cGMP guidelines + Disassembly of dirty equipment before and during cleaning. + ... Assembly of cleaned equipment parts, per Work Instructions. + Assist with setups and changeovers with adherence to SOPs and safety requirements. + Attendance at morning Tier meeting to understand and follow up on daily room and equipment cleaning needs. + All… more
- Cayuse Holdings (Raleigh, NC)
- …+ Translation Certifications. + Experience with State Department experience/ refugees, FDA , Health & Human services, Medical, Legal, Housing Authority etc. + ... Must be fluent inIntalia + Must be able to pass a background check. May requireadditionalbackground checks as required by projects and/or clients at any time during employment. + The ability tofacilitatetranslation with discretion and impartiality. +… more
- Novo Nordisk (Clayton, NC)
- …experience preferred + Minimum two (2) years of manufacturing experience in FDA regulated environment preferred + Experience demonstrating a systematic approach to ... problem solving & troubleshooting based on data & facts. Actively participated in & driven event response activities. Documented problems & worked on ensuring rapid resolution & preventing recurrence preferred + Experience following SOPs to perform tasks &… more
- Aerotek (Charlotte, NC)
- …monitoring production processes. **Additional Skills & Qualifications** + Prior knowledge of FDA facilities for safety audits. + Experience with general labor and ... cleaning in a production environment. **Why Work Here?** Enjoy working in a nice facility with an easy-going team that supports great growth opportunities. **Work Environment** Work in a clean, climate-controlled facility, ensuring comfort while performing… more
- Actalent (Durham, NC)
- …+ Proven experience in technical writing. + Experience with SOPs, GMP, and FDA regulations. + Experience with writing and optimizing protocols and change controls. + ... Experience in computer system validation and quality systems management. Additional Skills & Qualifications + Familiarity with audits and inspection readiness. Work Environment The position is based on-site in Durham, NC, within a start-up environment at a… more