- PCI Pharma Services (Philadelphia, PA)
- …new or improvement/expansion of existing assembly and packaging processes to deliver FDA compliant production capacity on time and within budget according to ... site facilities and utilities to accommodate new equipment and meet all regulatory requirements. + This position may require overtime and/or weekend work. Knowledge… more
- ZOLL Medical Corporation (Pittsburgh, PA)
- …Super Saturated Oxygen (SSO2) Therapy is the first FDA -approved therapy since the stent 20+ years ago to ... customers in proper product maintenance and use. . Ensure adherence to regulatory guidelines in product support activities. . Assist in time sensitive situations,… more
- Conagra (Milton, PA)
- …+ Develop the plant's health and safety programs in compliance with OSHA, FDA , USDA, and corporate standards. + Lead incident investigations and root cause analysis ... committees, encouraging engagement at all levels. + Be a liaison with regulatory agencies during inspections or investigations. + Support emergency preparedness and… more
- Lockheed Martin (King Of Prussia, PA)
- …for chemical processing systems, ensuring efficiency, safety, and compliance with regulatory standards\. * Collaborate with cross\-functional teams to review and ... skills\. * Active knowledge of relevant regulations, such as OSHA, EPA, and FDA guidelines, is desired\. * Active Top Secret security clearance is desired\.… more
- Charles River Laboratories (Horsham, PA)
- …with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling ... proudly supported the development of 86% of the drugs approved by the FDA in 2021. **Equal Employment Opportunity** Charles River Laboratories is an Equal… more
- Lilly (Philadelphia, PA)
- …with current local and international regulations, laws, guidance's (for example, FDA , ICH, CPMP etc.), Good Clinical Practices (GCPs), company standards, Lilly ... studies to support decisions regarding safety and efficacy as well as regulatory strategy, results summarization and publications + Provide expert interpretation of… more
- Teva Pharmaceuticals (West Chester, PA)
- …Technically independent and maintains up-to-date knowledge of Validation standards and regulatory compliance requirements + Work with subject matter experts to ... PREFERRED QUALIFICATIONS: + Knowledge of validation and quality compliance (cGMP/ICH/ FDA /USP/EP policies/guidelines) + Validation experience with production equipment, support… more
- BioLife Plasma Services (Harrisburg, PA)
- …and build your skills by contributing to financial, marketing, administrative, regulatory , quality, people, and facilities management. + **Contribute to Creating ... QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP, CLIA, and the FDA + Experience working in a highly regulated environment **We Offer Comprehensive… more
- West Pharmaceutical Services (Exton, PA)
- …within the ERP Services Delivery model, West policies and procedures as well as Regulatory requirements including but not limited to Sarbanes-Oxley and FDA GMP. ... + Create and maintain system lifecycle documents in accordance with West policies and procedures, including creation and maintenance of SOPs, SOIs and Job Aids. + Work within and participates in the Change Control process. + Conform with and abide by all… more
- Cook Medical (Pittsburgh, PA)
- …methodology associated with manufacturing a cell therapy product in an FDA -regulated environment.* Experience in Quality Assurance and/or Compliance functions and ... management guideline (Q9)* Experience in employee development* Experience with regulatory agency/health authority audits/inspections* Data analysis* Lean and Six… more