- Kedplasma (Pittston, PA)
- …procedure and plasma collection, including donor set-up, monitoring and disconnect in compliance with Standard Procedures and FDA guidelines, as needed. + ... scope of EU Guidance on Good Manufacturing Practice and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has...needed. + Records any required documentation accurately and in compliance with company SOPs. + Maintains data integrity and… more
- Brenntag AG (Reading, PA)
- …documentation, regulatory adherence, and internal audit processes to ensure compliance with industry standards and corporate policies. + Develop and monitor key ... policies, procedures, and quality manuals. + Hands-on expertise with regulatory frameworks and standards such as FDA ,...QA policies, procedures, and the quality manual to ensure compliance with evolving regulatory and industry standards.… more
- Penn Medicine (Philadelphia, PA)
- …and processes to promote patient/nurse safety. In partnership with Department of Regulatory Services, ensures compliance with all federal, state and local ... Develops and executes strategies to promote continual survey readiness. Evaluate compliance on ongoing basis. Provide leadership for regulatory /accreditation… more
- Merck (West Point, PA)
- …Provide technical oversight of cell culture process development, process characterization and regulatory filing activities to ensure a smooth and clear path to ... control strategies, process comparability reports, Process performance qualification, and/or regulatory submissions. + **CMC RA** : Experience supporting/writing … more
- Sumitomo Pharma (Harrisburg, PA)
- …encounters is considered confidential. ** Compliance ** : Achieve and maintain Compliance with all applicable regulatory , legal and operational rules and ... but not limited to, Clinical Development, Translational Medicine/Early Development, Regulatory Affairs, Data Management and Biostatistics is essential. **Job Duties… more
- Envista Holdings Corporation (Quakertown, PA)
- …growing, energetic, and diverse mix of professionals spanning engineering, operations, regulatory and quality backgrounds that work collaboratively in the fast-paced ... for ensuring that products are designed, developed, tested, and sustained in compliance with all applicable agency and market requirements. **PRIMARY DUTIES &… more
- ManpowerGroup (Milton, PA)
- …or processing industry. + Strong knowledge of sanitation chemicals, methods, and regulatory requirements ( FDA , USDA, GMP, SSOP, HACCP). + Experience managing ... all equipment, tools, and facility areas are cleaned and sanitized according to FDA , USDA, and company standards. + Develop and execute sanitation schedules and… more
- Penn Medicine (Philadelphia, PA)
- …the Division's Quality Assurance manager in functioning as liaison to accrediting/ regulatory agencies in preparation for inspections, site visits, documentation of ... compliance , deficiency corrections, status changes, and licensing renewals; Maintains...State, and local government agencies and professional accrediting agencies' regulatory requirements impacting lab operations including AABB, CMS (Center… more
- Honeywell (Pottsville, PA)
- …new drug product registration process including ICH stability guidelines. Familiarity with FDA , EMEA & Japanese Regulatory requirements relating to package ... and resources, ensuring that R&D projects adhere to industry standards, regulatory requirements, and Advanced Materials' quality and safety protocols. **KEY… more
- Penn Medicine (Philadelphia, PA)
- …+ Continuously improve unit/department operations to maintain and exceed internal/external regulatory compliance and achieve clinical excellence. + Participates ... intended to capture patient safety trends. + Supports the Nurse Manager in ensuring regulatory compliance : + (In partnership with Leadership Team) + Ensures … more