- BioLife Plasma Services (Camp Hill, PA)
- …+ Completion of all training through Lead Technician. Demonstrated understanding of quality assurance in an FDA -regulated environment. + Effective communication, ... performed consistently according to current Good Manufacturing Practices (cGMP), the Shire Quality System, and other applicable regulations for a plasma center. Is… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …obligations, and performs clinical assessments as requested. The ability to maintain quality documents to ensure compliance with FDA regulations and guidance ... reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting...initiates new or special assignments with occasional direction from Manager . Must have ability to work in a team… more
- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This...Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for… more
- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This...Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for… more
- Globus Medical, Inc. (Audubon, PA)
- …we move with a sense of urgency to deliver innovations that improve the quality of life of patients with musculoskeletal disorders. Our team is inspired by the ... for IDE/PMA submissions to the Food and Drug Administration ( FDA ) for class II and class III products. This...Obtaining and reviewing clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for… more
- University of Pennsylvania (Philadelphia, PA)
- …studies. This position will report directly to the Research Nurse Manager and work directly with Physician Investigators on clinical research performed. ... with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator (CRC) is… more
- Biomat USA, Inc. (Fairless Hills, PA)
- …daily operational plans to achieve center performance targets related to donor throughput, quality , and productivity. + Partners with Center Manager and ... donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts as a lead resource… more
- Grifols Shared Services North America, Inc (Williamsport, PA)
- …all state and federal regulations, US Food and Drug Administration ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health Administration ... standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and...is performed. * Under the guidance of the Center Manager and/or the Assistant Manager , assure facility… more
- Kelly Services (Malvern, PA)
- …Malvern, PA. + Work as primary investigator / Specialist to ensure consistent quality standards are maintained. + Collaborate with QA to initiate, author and drive ... with team to identify true root cause of investigations, assess product quality impact, and approve investigations as management technical representative, as needed.… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …across Medical & Scientific Affairs as well as Infection Prevention & Control, Quality Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care ... and experience working with: + Various regulations (HIPPA, EU-MDR, FDA 21 CFR Part 803, 806, 820) + Various...cross functional teams and contribute to the resolution of quality -related issues in a timely and effective manner. +… more