- GE HealthCare (State College, PA)
- …validation protocols. + Ensure compliance with regulatory standards (eg, ISO 13485, FDA QSR) and internal quality systems. + Manage capital equipment selection, ... in an engineering or operations role. + Experience in an ISO13485, FDA regulated or Medical Device manufacturing environment + Strong understanding of ultrasound… more
- BeOne Medicines (Pennington, NJ)
- …and release of materials, intermediates and finished products under FDA /EU regulations, applicable International Regulations, BeOne processes and procedures. ... Bachelor of Science degree and 5+ years of experience in an FDA -regulated biotechnology, pharmaceutical company with progressive levels of responsibility required. +… more
- Gummi World (Chandler, AZ)
- …discrepancies and implement corrective actions. + Ensure full compliance with cGMP, FDA requirements, and internal SOPs in all warehouse activities. + Maintain ... ERP for inventory management is required. + Strong knowledge of cGMP, FDA regulations, and audit readiness expectations. + Advanced Google Sheets skills including… more
- Caris Life Sciences (Phoenix, AZ)
- …compliance to all applicable regulatory requirements (CLIA, NYS, CAP, ISO, FDA , IVDD, etc.) with regards to laboratory instrumentation calibration and maintenance. ... + Three years of experience working in a regulated environment (CAP, CLIA, NYS, FDA , ISO, etc.) or Bachelor's degree in a biological science, engineering, or similar… more
- Abbott (Casa Grande, AZ)
- …in electrical upgrades and monitor contractor work.** + **Maintain compliance with FDA , OSHA, and company policies.** + **Stay current with advancing technology ... real impact. **You'll be accountable for meeting our compliance standards including FDA , OSHA and Abbott policies and procedures.** **Position Details** + **Shift:… more
- ZOLL Medical Corporation (Chelmsford, MA)
- …for test equipment, calibration requirements, and verification procedures in alignment with FDA and QSR standards. + Develop and execute validation plans for service ... industrial environment preferred + Experience working in a regulated environment; knowledge of FDA QSR and ISO 13485 preferred preferred + Familiarity with Lean, Six… more
- University of Rochester (Rochester, NY)
- …and complete source documentation in accordance with GCP and federal regulations ( FDA , NIH, OHRP) + Perform quality assurance reviews to ensure consistency between ... position adheres to national and international clinical research regulations including: FDA Clinical Trial Regulations + Office for Human Research Protections (OHRP)… 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 ... with a Bachelor's Degree + Prior experience working in an FDA regulated pharmaceutical manufacturing environment + Organizational skills including, but not… more
- University of Colorado (Aurora, CO)
- …ensure compliance with requirements of the Food and Drug Administration ( FDA ), study protocols, department, hospital/clinical standard operating procedures and other ... Assists with Sponsor, Data Safety Monitoring, and Food and Drug Administration ( FDA ) audits and responses + Participate in subject recruitment efforts, including… more
- Stanford Health Care (Palo Alto, CA)
- …Ordering, Furnishing or Prescribing of Drugs; Formulary Protocol] Medications that are not FDA -approved or are used for a non- FDA - approved indication (off-label ... use) require a patient-specific order in advance from the supervising physician. + After appropriate training, assists the supervising physician in the operating room (OR). + Acts as first or second assistant under the supervision of an approved supervising… more