- BioLife Plasma Services (Raleigh, NC)
- …or Bachelor's Degree + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated or high-volume retail environment + ... Excellent interpersonal, organizational, technical, and leadership skills \#LI-Remote **BioLife Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable… more
- Grifols Shared Services North America, Inc (Clayton, NC)
- …with an impact on product labeling. + Request and obtain all required FDA export documentation required for registration and routine product shipments. + Evaluate ... impact of new labeling regulatory requirements as well as evaluate changes to existing product labeling on assigned projects and products and inform other departments as necessary. + Maintain worldwide product registration status and distribute routine updates… more
- Burns & McDonnell (Raleigh, NC)
- …effective management of change orders. + Applies knowledge and understanding of FDA , cGMP, and other concepts, practices, codes, and procedures within the industry. ... + Demonstrated ability to develop designs in new or renovated facilities which integrate equipment, processes, and people. + Experienced in developing Process Architect deliverables across the Life Sciences industry including but not limited to Animal Health,… more
- Owens & Minor (Charlotte, NC)
- …Training Program. + Must meet job-related requirements to comply with DOT, FDA and standards of accrediting body. **Language Skills** + English (reading, writing, ... verbal). **PHYSICAL DEMANDS** While performing the duties of this job, the employee uses his/her hands to finger, handle or feel objects, tools or controls; reach with hands and arms; stoop, kneel, or crouch; talk or hear. The employee uses computer and… more
- ThermoFisher Scientific (Greenville, NC)
- …with all Current Good Manufacturing Practices (cGMPs) and ensure area compliance for FDA , QAT, and OSHA inspections. + Plan, monitor, and adjust daily production ... schedules to ensure efficiency and quality. + Coordinate department safety programs and ensure a safe working environment. + Evaluate personnel performance and skills, provide feedback, and conduct annual evaluations. + Assist technical staff and customers… more
- Charles River Laboratories (Raleigh, NC)
- …proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal ... Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status. If you are interested in applying to… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more
- GRAIL (Durham, NC)
- …with cross-functional teams to deliver scalable data solutions aligned with FDA and global health authority requirements. Our ideal candidate brings experience ... in the life sciences and a strong background in data processing, infrastructure and operational excellence. This hybrid role (60% of time onsite) and will be based Durham, NC in our state of the art lab. **Responsibilities** + Contribute to a highly… more
- ThermoFisher Scientific (Greenville, NC)
- …be considered. **Knowledge, Skills, Abilities:** Knowledge in GMP's and FDA regulations. Technical writing experience, preferred. Technical and operational knowledge ... of start-up of aseptic environment for live virus vaccines. Strong decision-making skills. The ability to handle multiple ongoing activities and ability to prioritize tasks. Outstanding attention to detail and organizational skills. Capable of flourishing in a… more
- United Therapeutics (Research Triangle Park, NC)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... lung disease (PH-ILD) and neuroblastoma, a rare pediatric cancer. Our near-term pipeline seeks to develop additional therapies for PAH and pulmonary fibrosis (PF). The cure for end-stage life-threatening diseases like PAH, PH-ILD, PF, and many others is an… more