- Merck (West Point, PA)
- …Expert knowledge of international GMPs and Quality Management requirements of various regulatory agencies that may include US FDA , EMEA, TGA, HPB, ANVISA, ... contamination control. + Expert knowledge of international GMPs and Quality Management requirements of various regulatory agencies such as US FDA , EMEA, TGA,… more
- Merck (Harrisburg, PA)
- …outcomes to identify trends, drive improvements, and report findings to senior quality and management councils. + ** Regulatory Consultation:** Offers proactive ... PhRMA, and ISPE to stay at the forefront of regulatory and quality best practices. **Qualifications:** +...vaccines). + Deep expertise in GMP requirements across multiple regulatory agencies ( FDA , EU, ROW) + Strong… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …papers, and literature reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ... Functions as team member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance. Performs routine assignments independently; supports and… more
- Brenntag AG (Reading, PA)
- …including policies, procedures, and quality manuals. + Hands-on expertise with regulatory frameworks and standards such as FDA , EMA, ICH guidelines, GMP, ... Oversee the maintenance, periodic review, and necessary updates of the regional quality manual, ensuring it reflects current regulatory standards, industry best… more
- Guthrie (Sayre, PA)
- …+ Minimum 3-5 years of direct experience in clinical or pharmaceutical-sponsored research or regulatory fields such as the FDA , NIH, or HHS. + Minimum 5 ... subjects can commence. + Advises The Guthrie Clinic senior leadership on HRPP regulatory issues. + Oversee FDA inspections, audits, AAHRPP accreditation, and… more
- University of Pennsylvania (Philadelphia, PA)
- …comply with all policies relating to the University of Pennsylvania, Penn Medicine, FDA , GCP and other regulatory standards. The Clinical Research Coordinator ... (CROs) (ie, source documentation, case report forms, study and regulatory binders, and patient binders). + Resolve data queries...the conduct of audits by study sponsors, CROs, the FDA , and other entities as required. + Process and… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …drug product. + Handling of destruction of pharmaceuticals drug products. + Support regulatory inspections ( FDA , DEA, VAWD/NABP, NJDOH etc.) + Ensure US ... Quality Assurance Associate - Inspection Department: Quality...activity will be preferred + Knowledge of GMP and regulatory requirements for the pharmaceutical industry. + Strong proficiency… more
- Glenmark Pharmaceuticals Inc., USA (Allentown, PA)
- …Deviations, CAPA, Change Control related to QA and warehouse operations + Support regulatory inspections ( FDA , DEA, VAWD/NABP, PADOH etc.) + Ensure US Allentown ... Quality Assurance Associate - Batch Release Department: ...activity will be preferred + Knowledge of GMP and regulatory requirements for the pharmaceutical industry. + Strong proficiency… more
- Grifols Shared Services North America, Inc (Williamsport, PA)
- …of interpersonal communication, organizational and problem-solving skills. Ability to understand FDA regulations. Strong integrity and commitment to quality and ... medicines, solutions and services in more than 110 countries and regions. ** Quality Systems Associate** Summary: Under the direct supervision of the Quality… more
- Nammo Defense Systems, Inc (Scranton, PA)
- Summary: Nammo Pocal is looking for an experienced and results-driven Quality Control Manager / ISO Management Representative with 5+ years of leadership experience ... in Quality control....in complex, high-reliability environments, driving continuous improvement initiatives, ensuring regulatory compliance, and supporting defense programs from prototype to… more