- Kedplasma (Altoona, PA)
- …Responsible for registering and screening donors under the direction of the Center Manager . Operates within the scope of EU Guidance on Good Manufacturing Practice ... and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...and meeting(s) in a timely manner as instructed by supervisor/ manager . + Cooperate with department personnel, as well as… more
- University of Pennsylvania (Philadelphia, PA)
- …essential. This position requires adherence to University of Pennsylvania, IRB, and FDA guidelines, and may occasionally involve off-site work or flexible hours, ... and research related presentations. Works closely with the Principal Investigator, manager , and study team to identify problems and develop solutions. Implement… more
- Bayer (Philadelphia, PA)
- …Pharmacy, Medicine, Nursing or equivalent experience is preferred; + Working knowledge of FDA , OIG requirements ; + A minimum of 1 year MSL experience ... Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …+ Demonstrates knowledge and experience working with: + Various regulations (HIPPA, EU-MDR, FDA 21 CFR Part 803, 806, 820) + Various standards (GCP, ISO 13485, ... ISO 14971) + Regulatory filings ( FDA IDE, 510K, EU-MDR CERs, SSCP, PMCFs, PSURs) +...and reportingPost market surveillance, escalations, and mandatory safety reporting requirements . + Endoscopic diagnostic and therapeutic procedures in the… more
- Kelly Services (Malvern, PA)
- …regulatory compliance and technical feasibility of proposed changes. + Serve as project manager for the change process and provide coordination to ensure timely and ... a SME during internal and external regulatory audits including FDA , EMA . + Extract process data from SCADA...Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws.… more
- Highmark Health (Pittsburgh, PA)
- …and testing processes in partnership with the pharmacy benefits manager . The successful candidate will possess excellent communication, analytical, and ... a fast-paced and collaborative environment. **ESSENTIAL RESPONSIBILITIES** + Monitor FDA -approvals, drug manufacturer pipelines, assess drug utilization reports, and… more
- Veterans Affairs, Veterans Health Administration (Pittsburgh, PA)
- …a student loan payment reimbursement program. You must meet specific eligibility requirements per VHA policy and submit your EDRP application within four months ... Learn more Permanent Change of Station (PCS): Not authorized Requirements Conditions of Employment You must be a US...moderate and/or high complexity testing (as categorized by the FDA ) in a clinical laboratory. Research laboratory experience does… more
- Grifols Shared Services North America, Inc (Williamsport, PA)
- …Quality Systems Manager to ensure center training programs follow procedural requirements as defined in the donor center SOP and/or training programs documents. ... Systems Associate** Summary: Under the direct supervision of the Quality Systems Manager , perform quality assurance and Training functions to ensure compliance with… more
- BioLife Plasma Services (Pittsburgh, PA)
- … (in state of licensure) for basic IV therapy Satisfactorily complete the FDA approved training requirements for BioLife Medical Support Specialist Two years ... Support Specialist (Plasma Center Nurse) works under the guidance of the Center Manager for operational guidance and under the management of the Center Physician for… more
- Penn Medicine (Philadelphia, PA)
- …Full-Time** **Job Summary:** The Patient Services Coordinator (PSC) assists the manager and/or physicians in maintaining a patient/customer focus, supports the ... expectations are communicated and met. In the absence of the manager , the PSC may take on additional responsibilities. **Accountabilities:** **Coordinator… more