- Biomat USA, Inc. (Fairless Hills, PA)
- …daily activities of donor floor operations, supervising staff, and supporting compliance with regulatory and quality standards. The Senior Operations Supervisor acts ... staff during assigned shifts. + Learns and maintains thorough familiarity and compliance with all state and federal regulations, US Food and Drug Administration… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …Affairs & Regulatory Affairs, Research & Development, Legal, and Health Care Compliance . **Job Duties** + Candidate with Bilingual skills - English and Japanese ... and experience working with: + Various regulations (HIPPA, EU-MDR, FDA 21 CFR Part 803, 806, 820) + Various...your ability to email, you may call our HR Compliance Manager at 1-888-Olympus (###). **Let's realize your potential,… more
- Globus Medical, Inc. (Eagleville, PA)
- …not limited to, accurately completing all documentation and complies with applicable FDA , state, OSHA, AATB, and ISO regulations and standards. This individual works ... are parts and inspected correctly up to company and FDA , state, OSHA, AATB, and ISO regulations and standards....MedTech Code, and all other company policies + Ensures Compliance with applicable governmental laws, rules, and regulations, both… more
- Globus Medical, Inc. (Audubon, PA)
- …and implants using CAD software (CREO). + Create and maintain project plans and FDA -compliant Design History Files (DHF) for each project. + Manages all aspects of ... assigned projects to ensure timely completion of tasks while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Perform… more
- Kedplasma (Pittston, PA)
- …procedure and plasma collection, including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + ... scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...needed. + Records any required documentation accurately and in compliance with company SOPs. + Maintains data integrity and… more
- Bayer (Philadelphia, PA)
- …Medical Inquires in collaboration with Medical Communications; + Adherence to SOP and FDA guidance for distribution of scientific information; + Adherence to SOP and ... compliance guidelines for all external contacts; + Prepares and...or equivalent experience is preferred; + Working knowledge of FDA , OIG requirements; + A minimum of 1 year… more
- Aerotek (Bethlehem, PA)
- …and ensuring products are properly stored. You will be working with FDA -regulated products where quality is paramount, requiring attention to detail and adherence ... the warehouse. + Maintain attention to detail, especially when dealing with FDA -regulated products. + Identify and correct mistakes promptly, ensuring compliance … more
- Grifols Shared Services North America, Inc (Williamsport, PA)
- …employees and supervise donor flow. * Learn and maintain thorough familiarity and compliance with all state and federal regulations, US Food and Drug Administration ... ( FDA )-approved Standard Operating Procedure Manual, Occupational Safety and Health...standards in accordance with Federal and State regulations, with FDA approved Standard Operating Procedure Manual, OSHA, CLIA and… more
- Geisinger (Danville, PA)
- …+ Supports inspections/audits from regulatory/recommending bodies including TJC, PA DEP, FDA , ACR, and DOH. + Supports/oversees use of advanced medical imaging ... in clinical areas to ensure employee, patient, and visitor safety and compliance with regulations and standards of best practice. + Performs personal, patient… more
- Highmark Health (Pittsburgh, PA)
- …a fast-paced and collaborative environment. **ESSENTIAL RESPONSIBILITIES** + Monitor FDA -approvals, drug manufacturer pipelines, assess drug utilization reports, and ... Assist in the development of Gateway's Drug Formularies by monitoring FDA -approvals and drug manufacturer pipelines, assessing drug utilization reports, and writing… more