- Insight Global (Midlothian, VA)
- …- 8 years of quality experience, in a regulated industry such as FDA regulated and pharmaceutical - Experience supporting computer system validation (CSV) activities ... across an organization - Has partnered with the commercial side of the business to support system changes and validation needs - Systems: Veeva or TrackWise more
- Terumo Medical Corporation (Los Angeles, CA)
- …on Interactions with Healthcare Professionals. Fully adhere to all applicable FDA regulations, international guidelines and Terumo's policies at all times. 12. ... Performs other job-related duties as assigned. **Job Responsibilities (continued)** **Working Conditions/Physical Requirements** 1. This is a field-based position. Must be able to drive personal automobile on a daily basis to/from customer accounts and drive… more
- ICON Clinical Research (San Antonio, TX)
- …and risk assessments. + Ensure compliance with global regulatory requirements, including FDA , EMA, and ICH guidelines. + Act as the primary liaison between ... clients, internal teams, and third-party vendors to ensure alignment and timely execution of project deliverables. + Work with planning to ensure that appropriate resources are available to complete the study to timeline. + Proactively identify and address… more
- Regeneron Pharmaceuticals (Warren, NJ)
- …6 years' experience as Software Developer and 3 years' experience in an FDA or similarly regulated environment or equivalent combination of education and experience. ... Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the US, benefits may include health and wellness programs (including… more
- Xeris Pharmaceuticals, Inc. (Chicago, IL)
- …external vendors required. * Detailed knowledge of ICH/GCP Guidelines and current US FDA regulations. * Experience with eClinical tools (eg eTMF, CTMS, EDC, etc). * ... Understanding of clinical study budgets and financial management practices. * Self-motivated and able to work independently and effectively in a matrix/team environment. * Ability to handle multiple projects, prioritize work and meet deliverables. * Ability to… more
- ZOLL Medical Corporation (Baltimore, MD)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... reduce infarct size in patients with the most severe heart attacks. Heart disease is the leading cause of death for both men and women in the US At ZOLL, your work will help to ensure cardiac patients get the life-saving therapy they need.ZOLL has been… more
- Hologic (Newark, DE)
- …Minimum of 5+ years in a maintenance-related role. + Experience working in an FDA -regulated environment is preferred. + You must possess a valid driver's license and ... reliable transportation. The annualized base salary range for this hourly role is $65,300 to $85,400 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education,… more
- Actalent (Maryville, TN)
- …(SOPs) designed to ensure the donor meets suitability criteria in accordance with FDA guidance and regulations. The Nurse also reviews normal donor laboratory test ... and refers abnormal test to the Physician for review. The Nurse works closely with the Medical Director or Licensed Center Physician(s) while making any decisions which directly impact donor suitability. The Physician Substitute also provides medical oversight… more
- Actalent (Random Lake, WI)
- …Essential Skills + Experience with GMP, sanitation, food safety, HACCP, and FDA regulations. + 1-2 years of previous sanitation experience, preferably in the ... Food and Beverage industry. + Ability to comply with Quality Management and Food Safety Management requirements. + Effective communication skills in English, both verbal and written. + Ability to prioritize workload and adapt to shifts in daily priorities. +… more
- Bristol Myers Squibb (Summit, NJ)
- …purification, and aseptic processing or lab technique + Knowledge of cGMP/ FDA regulated industry + Basic mathematical skills - General understanding of ... cGMPs + Technical writing capability + Proficient in MS Office applications + Background to include an understanding of biology, chemistry, medical or clinical practices + Pre-requisites: Prior experience in Manufacturing and/or scientific/engineering… more