- BeOne Medicines (Pennington, NJ)
- …drug preclinical, clinical and commercial requirements. + Familiarity with EMA and FDA regulatory requirements. + Effective communication, oral and written, in a ... multi-disciplinary, project-driven work environment. **Supervisory Responsibilities:** + Strategic and tactical planning with ability to convey business relevance to team + Ability to translate strategy into actionable goals and expectations for team members +… more
- HCA Healthcare (West Haven, UT)
- …with standards set forth by accrediting agencies: CAP, JCAHO, CLIA, FDA and CMS. Leads department accreditation preparation. + Oversees quality control/assurance ... programs related to test methodology, protocols, equipment and supplies. Actively participates in Continuous Quality Improvement. + Provides input into the design of workflows, systems and processes and implements corrective action plans for service/quality… more
- Reckitt (Wanamingo, MN)
- …protocols and reports to qualify manufacturing and cleaning processes. + Interacts with FDA when onsite for audit as a subject matter expert. + Leverages knowledge ... of unit operations and engineering principles to effectively troubleshoot processing and equipment issues. + Use business tools to investigate out of specification issues and recommend disposition of material. + Assess and implement improvements for Plant CIP… more
- Bristol Myers Squibb (Devens, MA)
- …cryogenic storage (LN2) is preferred + Experience with health authorities (ie, FDA ) for audit support + Experience and familiarity with electronic systems including ... SAP, and manufacturing execution systems (MES) including Syncade and DeltaV + Safety and Quality mindset; proven ability to build a culture around these values and to communicate critical information clearly and in a timely manner to team and to manager as… more
- University of Miami (Coral Gables, FL)
- …modality including but not limited to: Joint Commission, AHCA, ACR, FL DOH and FDA /MQSA. + Assist with the day-to-day operations within the department. This list of ... duties and responsibilities is not intended to be all-inclusive and may be expanded to include other duties or responsibilities as necessary. CORE QUALIFICATIONS Education: High School diploma or equivalent. Graduate of a Diagnostic Medical Sonography and/or… more
- University of Pennsylvania (Philadelphia, PA)
- …final follow-up. Secure signatures and forward documents/forms (eg, FDFs, PSPs, FDA 1572, etc.) to appropriate destinations; maintain Delegation of Authority log. ... + Participate in research meetings (eg, team, disease-site, etc.) and Sponsor/CRO teleconferences. Provide coverage and support to meet departmental and organizational staffing needs (ie lunches, sick calls, vacations, or when a specific team member's workload… more
- Aerotek (Chaska, MN)
- …** ️ Key Responsibilities** + Follow SOPs, work instructions, and FDA /ISO requirements in English + Independently perform formulation, filling, testing, and ... packaging tasks + Set up, calibrate, and troubleshoot reagent components and instruments + Conduct solution testing (pH, conductivity, density) to meet specifications + Ensure compliance with QSR, GMP, and ISO standards + Collaborate with cross-functional… more
- Bristol Myers Squibb (Summit, NJ)
- …+ BS degree or equivalent experience + Minimum 5 years of experience in FDA -regulated industry with at least 2 years of recent hands-on CSV and implementation ... experience related to manufacturing and laboratory local standalone computerized equipment and systems. **DUTIES AND RESPONSIBILITIES:** **Essential Functions:** Maintains all qualified and validated equipment and systems in compliance with policies,… more
- Walgreens (Ironton, MO)
- …with payers and pharmaceutical manufacturers (BOP, DEA, Medicare, accreditation bodies, compounding, FDA , etc.). + Complies with all federal and state laws and ... regulations and Company policies governing all drugs and products; maintains required records, documentation, and reports. Ensures completion of all required reporting. + Assures accurate and timely reporting of inventory for limited distribution drugs (LDD)… more
- Edwards Lifesciences (Irvine, CA)
- …complex quality issues and drive root cause & corrective action (RCCA). + Knowledge of FDA QSR (21 CFR 820), ISO 13485, and ISO 14971 risk management. + Proven ... ability to lead cross‑functional deliverables/efforts (R&D, Quality, Manufacturing, Supply Chain, Supplier Management). + Strong project management skills, including structuring project milestones. + Certifications such as ASQ CQE, CQA, CSSGB/CSSBB, or Six… more