- US Tech Solutions (Easton, PA)
- …sites and/or Louisville Distribution Center team. + Prepare for and support regulatory inspections and audits. + Lead the development and revision of SOPs. ... + Interact with the FDA and other governmental inspection agencies. + Provide leadership, guidance, mentorship, and training to staff and partner groups. **Basic… more
- J&J Family of Companies (Spring House, PA)
- …that automated systems are fit for intended use and follow applicable regulatory requirements (eg cG(a)MP) and company manufacturing standards throughout the entire ... Minimum of 6-8 year's experience. **Preferred:** + Knowledge of cGMPs and FDA regulations + Experience in robotic programing and maintenance + Experience, training,… more
- Coherent (Saxonburg, PA)
- …to ensure compliance with quality standards (eg, ISO 9001, AS9100, FDA /GMP as applicable). Maintain and update electronic document management systems (EDMS/PLM/ERP). ... control procedures and best practices. Prepare documentation packages for audits, regulatory inspections, and customer requests. Train staff in document control… more
- Globus Medical, Inc. (Audubon, PA)
- …+ Reports to Manager, Case Design + Creates and maintains project plans and FDA complaint Design history Files (DHF) for each case + Ensures timely completion of ... manager, while remaining in full compliance with Globus quality system and other applicable regulatory bodies + Adheres to the letter and spirit of the company Code… more
- UPMC (Pittsburgh, PA)
- …and orderliness of assigned work area and maintain supply areas according to regulatory standards. + Distributes and collects clean and used linen throughout the ... been identified by the Pharmacy to be readily available. + The items can contain FDA legend medication under the supervision of the Director of Pharmacy. + Will be… more
- Trinity Health (Langhorne, PA)
- …sciences and documents results of activities performed to comply with all regulatory and standard requirements. Notifies equipment users, CE Managers, and Regional ... knowledge and understanding of OSHA, NFPA, The Joint Commission, CAHO, EOC, FDA and other specific regulations and standards pertaining to clinical equipment service… more
- UPMC (Carlisle, PA)
- …been identified by the Pharmacy to be readily available. The items can contain FDA legend medication under the supervision of the Director of Pharmacy. Will be ... cleanliness, orderliness of assigned work area and maintain supply areas according to regulatory standards. + Store and stack items in the prescribed location within… more
- United Therapeutics (Harrisburg, PA)
- …their daughter's pulmonary arterial hypertension (PAH). Today, we have six FDA -approved therapies that treat PAH, pulmonary hypertension associated with interstitial ... level manner, dependent upon audience + Demonstrated knowledge of regulatory /compliance requirements including the Anti-Kickback Statute, False Claims Act, FCPA,… more
- Lundbeck (Norristown, PA)
- …Environment/Compliance** - Ability to apply knowledge of pharmaceutical and regulatory environment, including accountability and adherence to Lundbeck policies and ... procedures and FDA regulations regarding the promotion of pharmaceutical and medical products. **REQUIRED EDUCATION, EXPERIENCE AND SKILLS:** + Bachelor of Arts or… more
- Veterans Affairs, Veterans Health Administration (Pittsburgh, PA)
- …and maintains accurate records in compliance with accrediting agencies such as CAP/TJC/ FDA /AABB/CLIA. Uses independent judgment to consult and provide guidance to ... Knowledge of concepts, principles, methodology of medical laboratory technology, regulatory and accrediting agency requirements and medicolegal requirements sufficient… more