- Biomat USA, Inc. (Kannapolis, NC)
- …for overseeing day-to-day operational performance to ensure donor safety, regulatory compliance , and achievement of production goals. This role provides direct ... with operational management of a Plasma Collection Center, ensuring compliance with all applicable policies and regulations and overall...Manager is not present. + Collaborates with Training and Quality staff to ensure that training and quality… more
- Reckitt (Wilson, NC)
- …SCADA, DCS) for manufacturing / utility operations. + Serve as automation SME and ensure compliance with GxP, FDA , EU Annex 11, and 21 CFR Part 11 requirements. ... in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not...using AutoCAD Electrical or EPLAN. + Experienced in regulatory compliance : GMP, FDA , ISO 9001/13485, EHS, electrical… more
- Stryker (Durham, NC)
- …safety and operations._** **Environmental Health & Safety role responsibilities:** + Ensure compliance with OSHA, EPA, FDA , ISO 13485, and company-specific EHS ... will be performing a dual-function role responsible for **ensuring regulatory compliance , workplace safety, and engineering support** within a regulated medical… more
- Lilly (Durham, NC)
- …Mentor junior staff and develop training materials to promote inspection skills and quality awareness within the organization. ** Compliance & Documentation** : + ... visual inspection program and processes to ensure the highest quality standards. The ideal candidate will provide expert guidance...Ensure compliance with FDA and any other global applicable regulatory standards by… more
- Actalent (Winston Salem, NC)
- …engineering. + Understanding of full compliance for lab instrumentation, validation protocols, FDA compliance , audit, lab equipment, IQ, OQ, PQ. + Audit and ... + Ensure all laboratory activities are conducted in full compliance with cGMP and applicable quality system...FDA experience. Additional Skills & Qualifications + Education in… more
- Astellas Pharma (Sanford, NC)
- …of the Data Integrity program elements, including but not limited to, compliance gap assessments, collaborating with key stakeholders to ensure all elements of ... embedded and carried out through established work practices, to ensure compliance with Astellas local/global and regulatory requirements, and participating in… more
- Merck (Wilson, NC)
- …all of our Company Divisional policies and Wilson site procedure for safety, quality , and regulatory compliance . + Review literature pertaining to pharmaceutical ... This involves leading root cause analysis investigations for equipment-related quality events. + Provides written scientific justification for proposed changes… more
- BioFire Diagnostics, LLC. (Durham, NC)
- …working a 2-2-3 rotation schedule. This position is in a fast-paced, FDA regulated environment in the Medical Devices/Diagnostics Industry. The QC Biochemistry ... Loss on Drying, Resin Ratio, Reflectance, and pO2 Headspace Analysis, HPLC. + Quality + Ensures all testing documentation is completed in an accurate, thorough, and… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …manufactured products are appropriately measured and monitored according to Glenmark Monroe quality system requirements and regulatory guidelines (eg, FDA 21 ... Microbiology/EM Team Lead provides direct oversight and guidance in the Quality Control Microbiology and Environmental Monitoring (EM), including applicable support… more
- Fujifilm (Raleigh, NC)
- …vendor agreements, non-disclosure agreements, development, manufacturing and service agreements, quality agreements and clinical trial and research agreements, among ... legal risks and regulatory risks, including with respect to FDA regulations and other regulations specific to Life Sciences/Pharma...Experience in legal matters involving tariffs and other trade compliance issues would be a plus. + Strong contract… more