- Merck (West Point, PA)
- …substance and drug product container closure systems including mold qualification and regulatory compliance. To act as master data stewards and support enterprise ... commercialization teams across the end to end supply chain, and analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership and… more
- Merck (West Point, PA)
- …development and technology teams, supply chain, operations, quality, analytical, regulatory , and project leaders. The successful candidate will demonstrate ownership ... the assembly and packaging platform portfolio, including interrogation of the data/ science through technical reviews and exploring alternative ways to view and… more
- Merck (West Point, PA)
- …for MQSA. **Education Minimum Requirement and Experience:** + Bachelor of Science (BS) Degree in Microbiology, Biology, Medical Technology, Pharmacy, Microbiology, ... Chemical Engineering, or related science discipline with ten (10) years' experience in sterile...of international GMPs and Quality Management requirements of various regulatory agencies that may include US FDA, EMEA, TGA,… more
- Merck (West Point, PA)
- …mitigates risks across all factors that may impact technical, operational & regulatory success or timelines. Analyzes and develops innovative solutions to unforeseen ... circumstances. + Responsible to ensure the best science and most robust processes are used, working closely with DCRC. As the Product TPL takes ownership for the… more
- Merck (West Point, PA)
- …and 3rd party logistics sites, supply chain and technology teams, and regulatory and project leaders. The successful candidate will demonstrate ownership and make ... and execution excellence across the portfolio, including interrogation of the data/ science through technical reviews and exploring alternative ways to view and… more
- Vistra (Shippingport, PA)
- …Summary** This position reports to the Senior Manager, Licensing to provide regulatory services and support necessary for the safe, efficient and reliable operation ... and Perry). This position supports interface of Vistra with the US Nuclear Regulatory Commission (NRC) and other regulatory agencies to obtain and maintain… more
- ATS Automation (Warminster, PA)
- …serve as the first point of contact for trade export import and regulatory compliance inquiries working cross functionally with internal teams external partners and ... regulatory authorities. RESPONSIBILITIES Trade Compliance + Develop implement and...and production across diverse end-user markets including pharmaceuticals, life science , ophthalmic, environmental testing and monitoring, food and beverage… more
- PPL Corporation (Allentown, PA)
- …coordinates testing needs, communications and implementation of projects for both regulatory and non- regulatory work. Position participates in the ... and behaviors to meet changing business requirements and compliance with regulatory requirements in a retail choice environment. Responsibilities + Direct and… more
- Olympus Corporation of the Americas (Center Valley, PA)
- …reviews). The Analyst III requires a thorough understanding of FDA regulatory requirements for complaint handling and MDR reporting per ISO13485, 21CFR820, ... member/ leader, in fulfilment of corporate objectives for FDA regulatory compliance. Performs routine assignments independently; supports and mentors lower-level… more
- Merck (West Point, PA)
- …transfer to internal and external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. The group ... is responsible for establishing the science , engineering and knowledge required for today's innovative and...and qualification (PPQ) and shelf-life strategies. + Influences CMC regulatory strategy and is accountable for DP CMC sections… more