- Fujifilm (Raleigh, NC)
- …vendor agreements, non-disclosure agreements, development, manufacturing and service agreements, quality agreements and clinical trial and research agreements, among ... on general legal risks and regulatory risks, including with respect to FDA regulations and other regulations specific to Life Sciences/Pharma companies. + Provide… more
- Stryker (Durham, NC)
- …Health & Safety role responsibilities:** + Ensure compliance with OSHA, EPA, FDA , ISO 13485, and company-specific EHS standards. + Develop, implement, and maintain ... + Ensure engineering activities comply with applicable regulations, including FDA 21 CFR Part 820 and ISO 13485. **What... regulations, ISO 13485, and cGMP + Experience with maintenance/ quality systems a plus + Lean Manufacturing or Six… more
- Lilly (Durham, NC)
- …enhancing our visual inspection program and processes to ensure the highest quality standards. The ideal candidate will provide expert guidance on inspection ... technical knowledge, strong analytical skills, and a commitment to product quality and patient safety. **Key Responsibilities** : **Visual Inspection Program… more
- Cambrex High Point (Durham, NC)
- …customer-focused scientific and manufacturing excellence, as well as our strong commitment to quality and safety, we offer a range of career and growth opportunities ... Together with our customers, we aim to improve the quality of life for patients around the world. Start...development reports in accordance with SOPs and ICH and FDA guidelines. Typical testing includes analysis of potency, purity,… more
- Lilly (Concord, NC)
- …example and provide coaching to others in the areas of safety, quality , operational excellence, compliance, and continuous improvement. Direct line supervision for ... / Deliverables:** **Integrity** + Leading by example with a Safety first, Quality Always mindset. Comfortable with exercising and encouraging "Stop Work Authority"… more
- Astellas Pharma (Sanford, NC)
- …will be primarily responsible for the implementation, execution and assessment of quality systems, procedures, and records to support compliant GMP operations. This ... position works closely with Validation, Engineering, Manufacturing, Quality Control, Facilities, and Automation. **Responsibilities** + Provide hands on QA support… more
- ThermoFisher Scientific (Greenville, NC)
- …Work:** As an Engineer III, Validation, you will provide direct quality support through compliance, regulatory assessment, and validation activities. You will ... guide lower-level staff, ensuring accurate and timely completion of quality functions. This position involves frequent decision-making, coordination, and… more
- Grifols Shared Services North America, Inc (Goldsboro, NC)
- …donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a lead resource ... daily operational plans to achieve center performance targets related to donor throughput, quality , and productivity. + Partners with Center Manager and Quality … more
- BioFire Diagnostics, LLC. (Durham, NC)
- …improvement efforts through the use/implementation of documentation innovation and quality related processes; thereby aligning and consolidating procedural documents ... controlled documents in accordance with company policies and regulatory agency (eg, FDA and ISO) requirements. + Provide assistance with the review and revision… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …following standard operating procedures (SOP) and batch records in accordance with FDA current Good Manufacturing practices (cGMP). In addition, personnel in this ... batch records and production of material promptly and with the highest quality standards. + Maintain documentation and functional work areas to GMP standards.… more