- Philly Shipyard Inc (Philadelphia, PA)
- …development and implementation of owner change order requests Communicate with class, USCG, FDA and any other required regulatory agency to resolve any regulatory or ... inspection issues raised during construction of the vessel Assist with the startup and commissioning of hull outfitting equipment and systems. Participate in dock testing and possibly Sea Trials. Document any issue and revise procedures accordingly. Assist… more
- Teva Pharmaceuticals (West Chester, PA)
- …QUALIFICATIONS: + Knowledge of validation and quality compliance (cGMP/ICH/ FDA /USP/EP policies/guidelines) + Validation experience with production equipment, support ... equipment, HVAC and other utilities, analytical lab equipment, computerized systems/automation, CIP, and cleaning verification + Cooperative, independent, critical thinking, multi-tasking and detail oriented + Excellent oral and written communication skills +… more
- Lilly (Philadelphia, PA)
- …lab management + Demonstrated advanced understanding of cGMPs, ICH Quality guidance, FDA CMC guidance + Demonstrated ability to communicate complex issues accurately ... and succinctly, both horizontally and vertically across the development organization **Preferred Skills/Experiences:** + PhD in analytical chemistry + Excellent scientific knowledge in analytical chemistry and experience with using traditional and advanced… more
- Globus Medical, Inc. (Audubon, PA)
- …several stages of development (ie existing portfolio, near-term launch, pending FDA approval and new products). Supports product lifecycle management, product ... roadmap, technique, new product training and product launch readiness with revenue goals in mind. **Essential Functions:** + Keeps a strong pulse on the market by attending trade shows, VIP surgeon events, spine surgeries and labs + Collaborates with upstream… more
- BioLife Plasma Services (Harrisburg, PA)
- …or Bachelor's Degree + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated or high-volume retail environment + ... Excellent interpersonal, organizational, technical, and leadership skills \#LI-Remote **BioLife Compensation and Benefits Summary** We understand compensation is an important factor as you consider the next step in your career. We are committed to equitable… more
- Teva Pharmaceuticals (West Chester, PA)
- …laboratory computer systems. Ensures that system implementations are in keeping with the relevant FDA 21 CFR Part 11, GxP guidelines as well as internal policies and ... processes. * Ensure compliance with Data Integrity requirements and remediation activities for Laboratory systems. * To be the site expert on all laboratory computer systems - LIMS (Labware), CDS (Empower), standard-alone computer driven instrumentation and… more
- Papa John's International (Freedom, PA)
- …Sanitation and HACCP policies & procedures, federal, state and local regulations (OSHA, FDA , DOL) and all Papa John's International, Inc., policies & procedures. + ... Perform other duties as assigned. It is the policy of Papa John's to provide equal employment opportunities for all applicants and team members without regard to race, color, religion, sex, age, marital status or civil partnership, national or ethnic origin,… more
- 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