- Philips (New Kensington, PA)
- …Post Market Quality/Respiratory Care, with proven experience working within FDA regulated Complaint Handling/Vigilance Reporting medical device environments. + You ... have experience leading Post Market/Complaint Handling teams/projects, including training in complaint handling, ensuring timely/effective responses to customer issues, and fostering a culture of continuous improvement/excellence in customer relations within… more
- Fujifilm (Harrisburg, PA)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and all ... other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications:** + BA/BS or equivalent, preferably with… more
- Boehringer Ingelheim (State College, PA)
- …+ Performs all Company business in accordance with all regulations (eg, EEO, FDA , etc.) and Company policy and procedures. When violations are noted/observed they ... are to be immediately reported to management. Demonstrates high ethical and professional standards with all business contacts in order to maintain BIAH's excellent reputation within the animal health community and internally. **Requirements** Sales… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... + Facilitates MES (Camstar) / ERP (Epicor) validation activities in an IS0-13485/ FDA regulated environment. + Supports product and process change implementation by… more
- Teva Pharmaceuticals (West Chester, PA)
- …global submissions + Experience with Veeva as EDMS + Knowledge of ICH/ FDA /EU guidelines (clinical documents and publishing) and regulations **Enjoy a more rewarding ... choice** We offer a competitive benefits package, including: Comprehensive Health Insurance: Medical, Dental, Vision, and Prescription coverage starting on the first day of employment, providing the employee enrolls. Retirement Savings: 401(k) with employer… more
- BioLife Plasma Services (Harrisburg, PA)
- …QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated environment **We Offer Comprehensive ... Benefits from Day One** + Major medical, dental, and vision insurance and prescription coverage for eligible employees + A minimum of 15 vacation days and 10 company paid holidays + Tuition reimbursement + Retirement savings with a generous employer… more
- West Pharmaceutical Services (Exton, PA)
- …as well as Regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP. + Create and maintain system lifecycle documents in accordance with West ... policies and procedures, including creation and maintenance of SOPs, SOIs and Job Aids. + Work within and participates in the Change Control process. + Conform with and abide by all regulations, policies, work procedures, instruction, and all safety rules. +… more
- Penn State Health (Lancaster, PA)
- …All testing is performed in accordance with laboratory policies and procedures, FDA , CAP, OSHA, CUA, and Joint Commission regulations and guidelines. Test results ... are used in the diagnosis, treatment. and prevention of disease. **MINIMUM QUALIFICATION(S):** + Associates degree for Medical Laboratory Technician or bachelor's degree in a chemical, physical, or biological science required. + Eligible to take the ASCP Board… more
- Penn State Health (Lancaster, PA)
- …according to physician orders in accordance with laboratory policies and procedures, FDA , CAP, AABB, OSHA, CUA, and JCAHO regulations to facilitate optimum quality ... patient care. Tests are used in the diagnosis and treatment of disease and include specimen processing, test performance and maintaining of test results. Some procedures are complex and require professional judgment. **MINIMUM QUALIFICATION(S):** + Bachelor's… more
- Honeywell (Pottsville, PA)
- …drug product registration process including ICH stability guidelines. Familiarity with FDA , EMEA & Japanese Regulatory requirements relating to package design and ... selection for pharmaceutical products. + Ability to apply statistical analysis to evaluate data with hands on Statistical Process Control (SPC) experience. Honeywell helps organizations solve the world's most complex challenges in automation, the future of… more