- Hologic (Marlborough, MA)
- …engineering, we encourage you to apply! **Knowledge:** + Strong understanding of FDA Quality System Regulations, including Design Control requirements, ISO 13485, EU ... year** with a PhD in a related field. + Experience in an FDA -regulated industry preferred. + Hands-on experience in root cause analysis, complaint investigations,… more
- Vitality Works Inc (Albuquerque, NM)
- …industry experience in pharmaceutical or similar industry or work in a FDA /ISO highly regulated environment strongly preferred. + Working knowledge of multiple human ... vitamin and nutraceutical supplements to help people get and stay well. While the FDA defines minimum quality, we strive for the highest level of quality. Vitality… more
- Vitality Works Inc (Albuquerque, NM)
- …vitamin and nutraceutical supplements to help people get and stay well. While the FDA defines minimum quality, we strive for the highest level of quality. Vitality ... team + Stay abreast of industry news, trade shows, periodicals, trends, FDA communications and industry regulations + Work with other departments in communicating… more
- Astrix Technology (Los Angeles, CA)
- …2 years management experience. Experience drafting & rewriting SOPs, audits, FDA filings/docs, CAPAs, change controls, batch records, documentation. Knowledge of ISO ... 22716 & FDA regulations INDBH We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race,… more
- Kelly Services (Princeton, NJ)
- …testing and release of materials, intermediates, and finished products under FDA , EU, and international regulations. The candidate will lead laboratory ... scientific discipline. + **7-12 years of experience in an FDA -regulated pharmaceutical or biotechnology environment** , with demonstrated experience supporting… more
- United Therapeutics (Christiansburg, VA)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... Animal Welfare and other federal regulations regarding animal research including USDA, FDA and DEA + Working knowledge of facility maintenance, including mechanical,… 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
- Stryker (San Jose, CA)
- …+ Collaborate with cross-functional teams to ensure compliance with ISO 13485, FDA regulations, and internal quality systems. + Promote a customer-centric quality ... Management, and Supplier Quality. + Familiarity with ISO 13485, ISO 14971, and FDA regulations. + Excellent communication and leadership skills; ability to train and… more
- United Therapeutics (Silver Spring, MD)
- …pulmonary arterial hypertension ( **PAH** ). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial lung ... with a Bachelor's Degree + 2+ years of experience in an FDA regulated pharmaceutical manufacturing environment, with emphasis on manufacturing system administration,… more