- American Red Cross (NC)
- …and regulatory standards for Cell Therapy Laboratory operations (FACT, FDA , CLIA), drive process standardization, and support workforce development.** **External ... growth, manage multidisciplinary teams, and maintain compliance with FACT, CLIA, and FDA standards. Develop new theories and solutions, conduct research of emerging… more
- Chiesi (Cary, NC)
- …published by OPDP, and by attendance of major FDLI, DIA and other industry/ FDA meetings. + Ensures that changes in US Prescribing Information are reflected in ... regulations for drug promotion/advertising and US labeling, and experience interacting with FDA OPDP + Experience with Veeva Vault PromoMats and MedComms, Trackwise,… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …monitored according to Glenmark Monroe quality system requirements and regulatory guidelines (eg, FDA 21 CFR, USP, EU Annex-1). This position is in a fast-paced, ... FDA regulated environment in the Pharmaceutical Industry. QC Microbiology/EM Team Lead is a key position with expected knowledge and comprehension of subject matter… more
- IQVIA (Durham, NC)
- …make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Rare Disease or Pediatrics. Experience ... be given to candidates with recent previous health authority experience (current or ex- FDA medical reviewers, etc.) and with strong a ba_** **_ckgroun_** **_d in_**… more
- Reckitt (Wilson, NC)
- …engineering, maintenance, and production teams. + Maintain regulatory alignment (GMP, FDA , ISO, EHS) and current schematics. + Execute preventive maintenance and ... compliance, and electrical codes..Strong knowledge of regulatory standards (eg, GMP, FDA , ISO 9001/13485). + PE (Professional Engineer) License or EIT certification… 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 ... method/validation regulations. + Experience participating in the management of regulatory audits (ie FDA , MDSAP, ISO, OSHA, EPA, etc.). + Experience in the use of… more
- Reckitt (Wilson, NC)
- …+ Compliance & Documentation: Ensure all processes comply with cGMP, FDA , and Reckitt quality standards. Maintain accurate and complete documentation (batch ... and oral solid dosage (OSD) forms. + Strong understanding of GMP, FDA regulations, and pharmaceutical manufacturing standards. + Hands-on experience with key… more
- Lilly (Concord, NC)
- …in quality initiatives and audits. Provides leadership for compliance to FDA , OSHA, EPA regulations. + Identifies and implements performance improvements + ... the importance of and basic requirements of regulatory agencies such as the FDA , OSHA, and EPA + Demonstrate solid judgement and initiative + Enthusiastic, positive… more
- Lilly (Concord, NC)
- …Solid understanding of basic requirements of regulatory agencies such as the FDA , EMEA, DEKRA, and/or OSHA. + Excellence in; interpersonal, electronic, written, and ... in manufacturing/operations with 2+ years in supervisory role + cGMP standards and FDA (or other industry) guidelines for production + Aseptic filling, single use… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …by following standard operating procedures and batch records in accordance with FDA Current Good Manufacturing Practices. In addition, personnel in this position ... 7 Years- experience in CGMP/Aseptic Operations Background Knowledge & Skills: + FDA /CGMP/Mechanical Aptitude/Process SME + Working Lead, sets tone for area specific… more