- 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 ... internal key stakeholders including, but not limited to; Finance, Safety, Quality Assurance, Operations, Regulatory, Product Development, Medical Affairs; which may… more
- Fujifilm (Holly Springs, NC)
- …This role ensures equipment and systems comply with regulatory requirements and quality standards while ensuring a successful integration of CQV activities into site ... validated per standards and regulatory requirements (eg, Food & Drug Administration ( FDA )) * Reads piping & instrumentation diagrams (P&IDs) to walkthrough systems… more
- Catalent Pharma Solutions (Greenville, NC)
- …site. Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer and Catalent ... regulations + Working knowledge of current Good Manufacturing Practices (cGMPs) and FDA /industry standards + Demonstrated ability to be a creative and proactive… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …skylights, docks and etc. + Handles return goods, segregating product awaiting Quality disposition or return to stock according to procedures. + Prepares and ... and/or warehouse, logistics, production manufacturing experience in a regulated industry ( FDA , USDA, NRC) OR Three years of warehouse experience in a… more
- Kedplasma (Hickory, NC)
- …Manager. Operates within the scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been made to make ... units and timely placement of units/samples into freezer per SOPs to ensure product quality . + Ensures only one plasma unit and samples are properly labeled at a… more
- System One (Sanford, NC)
- …multiple projects and priorities in a fast-paced environment. + Familiarity with GMP, FDA , or other regulatory standards is a plus. Preferred Experience: + 3+ years ... We help clients get work done more efficiently and economically, without compromising quality . System One not only serves as a valued partner for our clients,… more
- Aerotek (Concord, NC)
- …as assigned. **Responsibilities** + Perform duties with a focus on safety, quality , and Good Manufacturing Practices. + Conduct scheduled preventative maintenance on ... at a high-speed production facility with over 900,000 square feet of FDA -certified space, conveniently located for easy access to supply chain networks. Benefit… more
- Medtronic (Charlotte, NC)
- …to company policies and procedures + Adheres to financial, regulatory, quality compliance standards and requirements. **Influence and Selling:** + Identify, ... in a manner that adheres to ethics & compliance guidelines and FDA requirements **Communication:** + Work with internal functions (marketing, customer service,… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …One to two years of experience in Manufacturing, Pharmaceutical or other FDA licensed Industry or documented and demonstrated abilities to meet requirements through ... with minimum supervision and follow detailed directions. 7. Ability to perform quality work in a fast-paced environment with rapidly changing priorities. 8. Ability… more
- Sanofi Group (Charlotte, NC)
- …role, the TEM will assist patients and caregivers with accessing Sanofi's FDA -approved 14-day T1D infusion therapy. The CE provides disease and product information ... family, with a wide range of health and wellbeing benefits including high- quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral… more