- Charles River Laboratories (Wayne, PA)
- …worked on 80% of the drugs approved by the US Food and Drug Administration ( FDA ) in the past five years. We're committed to providing benefits that elevate your ... quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.… more
- University of Pennsylvania (Philadelphia, PA)
- …meetings and will be expected to adhere to all University of Pennsylvania, FDA , and GCP guidelines. The CRC-B/C will be responsible for accurate data collection ... and overseeing the quality of the clinical trial data and records, scheduling and conducting study initiation and monitoring visits, and participating in ongoing study protocol training. The CRC B/C is also responsible for research lab specimen… more
- J&J Family of Companies (Horsham, PA)
- …of Health Care Compliance programs and policies, Federal health care programs, and FDA requirements required. + Consistent track record of working in a collaborative ... environment with demonstrated evidence of maintaining relationships and partnerships with peers and business partners. + Experience with supporting product launches is preferred. + Broad business experience and a proven ability to influence business decisions… more
- Penn Medicine (Philadelphia, PA)
- …with all applicable federal, state, and local regulatory standards (ex TJC, DOH, FDA , HIPAA, HCFA, DPW, LCGME, SCGME, etc). + Flexible and readily adopts new ... processes and engages in practice operation changes. + Performs duties in accordance with Penn Medicine and entity values, policies, and procedures. + Other duties as assigned to support the unit, department, entity, and health system organization.… more
- Globus Medical, Inc. (Audubon, PA)
- …prototyping, development testing, design verification and validation, manufacturing, FDA approvals, product introduction and post introduction monitoring. This ... individual will work with spine surgeons and all other functions of the company to ensure high quality and on-time product introductions. **Essential Functions:** + Designing and developing instruments and implants using Pro/E software + Working with in-house… more
- ManpowerGroup (Zelienople, PA)
- …+ At least one year of experience performing electro-mechanical inspections in an FDA or ISO regulated environment. + Basic familiarity with MS Office Products ... (Word, Excel, Outlook). + Knowledge of mechanical and physical inspection techniques and tools (calipers, micrometers, depth gauges, etc.). + Ability to perform various testing procedures and simple statistical analysis related to sampling. **What's in it for… more
- Sanofi Group (Swiftwater, PA)
- …**Job Duties and Responsibilities:** + Ensuring that processes are always compliant with FDA regulations. + Works to become trained in all assigned training modules. ... + Identifying and preventing deviations and assisting in investigation and root cause analysis. + Helping with deviation investigations, Corrective and Preventive Actions (CAPA), Change Control Requests (CCR), and other assigned projects. + Ensuring that… more
- Sumitomo Pharma (Harrisburg, PA)
- …and risk management regulations and guidelines, including pre- and post-marketing US FDA and/or EU ICH safety requirements** + Expertise in medical review of ... medical review of Individual case safety reports and aggregate safety reports + Knowledge of drug development in the pharmaceutical industry, including clinical research and global regulatory requirements + Experience managing safety data, expedited individual… more
- ThermoFisher Scientific (King Of Prussia, PA)
- …of laboratory requirements, PPD & client SOPs, ICH guidelines, USP requirements and FDA guidance + Ability to utilize Microsoft Excel and Word to perform tasks. ... **Physical Requirements / Work Environment** Thermo Fisher Scientific values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working… more
- CSL Plasma (Philadelphia, PA)
- …donor disconnect. 2 In compliance with SOPs and Food & Drug Administration ( FDA ) guidelines, performs venipuncture on donors to begin pheresis process. 3 Evaluates ... vein performance of the donor to identify possible problems; makes necessary corrections in order to expedite donation time and ensure product quality and donor safety. Ensures donation process is efficient and makes adjustments when necessary to make the… more