- West Pharmaceutical Services (Williamsport, PA)
- …within a regulated, high-precision environment. The ideal candidate will ensure compliance with ISO 13485, and GMP requirements, while driving continuous improvement ... manufacturing outcomes. + Oversee process validation activities (IQ/OQ/PQ) in compliance with ISO 13485 requirements. + Drive continuous improvement initiatives… more
- University of Pennsylvania (Philadelphia, PA)
- …all sponsored projects expenditures including fund projections. Monitor and enforce compliance with sponsor guidelines and meet with Principal Investigators to ... all sponsored projects expenditures including fund projections. Monitor and enforce compliance with sponsor guidelines and meet with Principal Investigators to… more
- United Therapeutics (Harrisburg, PA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... with vendors and partners to ensure the highest level of quality and compliance with respect to ISCR processing and reporting. The Lead Pharmacovigilance QC… more
- Penn Medicine (Philadelphia, PA)
- …others as requested. Proactively prioritizes recovery of missing charges. Regulatory Compliance : + Complies with educational and training requirements at prescribed ... intervals (via Knowledge Link and/or other methods as required). + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC,… more
- Penn Medicine (Philadelphia, PA)
- …as requested. Proactively prioritizes recovery of missing charges. **_Regulatory Compliance :_** + Complies with educational and training requirements at prescribed ... intervals (via Knowledge Link and/or other methods as required). + Ensures compliance with all applicable federal, state, and local regulatory standards (ex TJC,… more
- Globus Medical, Inc. (Eagleville, PA)
- …is not limited to, ensuring all policies and procedures comply with applicable FDA , state, OSHA, AATB, and ISO regulations and standards. This individual works with ... the AdvaMed Code, MedTech Code, and all other company policies + Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United… more
- Veterans Affairs, Veterans Health Administration (Pittsburgh, PA)
- …supplies. documents all quality control activities and maintains accurate records in compliance with accrediting agencies such as CAP/TJC/ FDA /AABB/CLIA. uses ... along with continuing education and employee orientation to ensure staff compliance with safety requirements. Reference: For more information on this qualification… more
- Sanofi Group (Pittsburgh, PA)
- …role, the TEM will assist patients and caregivers with accessing Sanofi's FDA -approved 14-day T1D infusion therapy. The CE provides disease and product information ... delivery of the interaction. CE's must also ensure full compliance with all corporate and industry policies and legal...to travel extensively (60 to 80%) + Ensures full compliance with all corporate and industry policies and legal… more
- CSL Plasma (Temple, PA)
- …* In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. * Evaluates vein ... the pheresis process and following Standard Operating Procedures (SOPs). * In compliance with SOPs, performs all aspects of the pheresis procedure and plasma… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …requirements + Review and maintaining existing Quality System and ensuring compliance to Agency Regulations/cGMP expectations + Maintaining employee training and ... all incoming batches per current approved procedure + Support regulatory inspections ( FDA , DEA, VAWD/NABP, PADOH etc.) + Carry out other QA departmental… more