- GE HealthCare (State College, PA)
- …a manufacturing environment through employment or internships. + Experience in a FDA , ISO13485, or other highly regulated environment preferred. + Demonstrable use ... of a structured approach when analyzing and evaluating alternatives to manufacturing issues. \#LI-SAM1 \#LI-ONSITE \#LI-PA GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare… 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. **Qualifications:** Lead technical professional experienced in designing, implementing, documenting, and executing complex technical projects. A person in this position is expected to possess an expert level… more
- Sanofi Group (Swiftwater, PA)
- …in working with a production department of a pharmaceutical company. + Experience in FDA Regulated Industry + Working knowledge of cGMP's **Why Choose Us?** + Bring ... the miracles of science to life alongside a supportive, future-focused team. + Discover endless opportunities to gain experience and drive your career, whether it's through a promotion or lateral move, at home or internationally. + Enjoy a thoughtful,… more
- Sanofi Group (Swiftwater, PA)
- …view + Siemens: WinCC Familiar with local and federal code requirements such as FDA CFR, NFPA/ NEC, OSHA, DEP, EPA and industry standards & guidelines including ISA, ... ISPE, GAMP5. Familiar with process and utility equipment such as fermentation, purification, clean steam generators, Water For Injection (WFI), Clean/ Sterilize In Place systems (CIP/ SIP) systems, Building HVAC controls, and water/wastewater treatment… more
- Sanofi Group (Swiftwater, PA)
- …activities. As such, they may interact with representatives of Regulatory Agencies ( FDA , MHRA, PMDA, NMPA, ANSM, EMA, etc.). **ACCOUNTABILITY** The position reports ... to the CQA Team Manager. The position is considered fully remote with the need to attend onsite meetings occasionally as requested by CQ&CI/CQA Management. For full transparency, should the hired individual decide at some point to change positions within the… more
- Cytel (Harrisburg, PA)
- …team of consultants and analysts. + Experience interacting with regulatory agencies ( FDA /EMA) and key opinion leaders to enhance development plans. + Collaborative, ... entrepreneurial and self-motivated, with an understanding of the dynamics of high-growth companies; the ability to work effectively in a challenging and sometimes rapidly changing environment. + Minimum of a Masters in Mathematics, Biostatistics, or a related… more
- PCI Pharma Services (Philadelphia, PA)
- …procedures, along with all federal, state and local regulations, including OSHA, FDA , cGMP standards and employment law + Demonstrate substantial knowledge of the ... pharmaceutical industry, including cGMP, regulatory compliance, best practices, emerging trends and be the subject matter expert and escalation point for all complex, high impacting operating decisions. + Responsible for the Operations Safety culture and… more
- Globus Medical, Inc. (Limerick, PA)
- …for ensuring all policies and procedures in compliance with applicable FDA , state, OSHA, AATB, and ISO regulations and standards. **Essential Functions:** ... * Performs quality control inspections on manufacturing supplies, labels, in-process materials, and sterile packed finished products. * Performs peel testing of sterile product seals. * Follows verbal and/or written instructions such as production… more
- Fujifilm (Harrisburg, PA)
- …II + 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:** Professional Experience: + 5-10 years… 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. Key Performance Indicators: + Revenue and sales bookings… more