- Fujifilm (Holly Springs, NC)
- …in Validation, cGMP manufacturing operations and/or Quality oversight, in an FDA regulated facility. + Experience in Commissioning, Qualification, and Validation ... operations and/or Quality oversight, in a Food and Drug Administration ( FDA ) regulated facility. **Preferred Requirements:** + Experience and working knowledge of… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …the pharmaceutical, biotech, or CRO industry. + In-depth knowledge of ICH-GCP, FDA , EMA, and other global regulatory requirements related to clinical research. + ... + Experience working with CROs or external vendors. + Exposure to FDA or other health authority inspections. **Competencies** **Accountability for Results -** Stay… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …quota management, recordkeeping, and reporting. + Working knowledge and understanding of FDA /ICH/USP requirements, including FDA 21 CFR Parts 210, 211, and ... Part 11 (and Part 820, if applicable), ICH Q7 + Strong understanding of GMP requirements and global regulatory expectations for controlled substances. + Experience managing quality systems (eg, deviations, CAPA, change control, complaints) in a regulated… more
- Coty (Sanford, NC)
- …areas including HTS classification, country of origin, customs valuation, reconciliations, FDA requirements, USMCA qualification, and Section 232. + Lead customs ... hands-on work with HTS classification, valuation, country of origin, and FDA requirements. + Proven experience managing duty drawback programs. + Demonstrated… more
- BD (Becton, Dickinson and Company) (NC)
- …+ Documentation: Complete service administration activities promptly, adhering to ISO, FDA , and BD policies. **Minimum** **Qualifications:** + Associate's degree or ... + Experience in a lab or hospital environment + Familiarity with ISO, FDA , and company policies + Ability to support the sale of service contracts.… more
- IQVIA (Durham, NC)
- …make a significant impact in the field. A strong background in current FDA regulatory expectations and the global landscape in Oncology is preferred. **Essential ... given to candidates with recent previous health authority experience (current or ex- FDA medical reviewers, etc.)_** **Qualifications** + MD Degree required. + 15+… more
- Medtronic (Charlotte, NC)
- …in the operating room, so healthcare/surgical setting experience + Familiarity with FDA product requirements and regulatory guidelines + Experience with robotics or ... Ability to read and understand schematics and engineering drawings + Familiar with the FDA 21 CFR, CGMP for Medical devices + Demonstrable skills in Microsoft Office… more
- Glenmark Pharmaceuticals Inc., USA (Monroe, NC)
- …including, but not limited to, 21 CFR Parts 11, 210, and 211, and FDA data integrity guidance KNOWLEDGE, SKILLS AND ABILITIES: Education + Bachelor-s degree or ... results + Experience with pre-submission audits + Experience with FDA data integrity Leadership/Managerial attributes + Collaborative mind-set + Management… more
- United Therapeutics (Research Triangle Park, NC)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... practices **Preferred Qualifications** + 3+ years of experience in the FDA regulated pharmaceutical manufacturing environment + SAP Certification **Job Location**… more
- Kelly Services (Dallas, NC)
- …impact the company. 2. Independently research regulatory information related to US FDA , USDA, and Canadian and Mexican regulations. 3. Prepare accurate and timely ... and product compliance, labeling, and claims. 4. Strong knowledge of FDA food regulations. 5. Excellent organizational, analytical, and problem-solving skills. 6.… more