- PCI Pharma Services (Philadelphia, PA)
- …network to pioneer and shape the future of PCI. The Sr. Operations Manager is responsible for the safety, quality, and operational excellence for Advanced Drug ... along with all federal, state and local regulations, including OSHA, FDA, cGMP standards and employment law + Demonstrate substantial knowledge of the pharmaceutical… more
- Cook Medical (Pittsburgh, PA)
- …helping others, and driven by integrity, we invite you to apply. The Manager , Investigations, CAPA and Complaints at Cook MyoSite, Inc. is responsible for overseeing ... all activities performed by the Investigations Writing team. The manager works closely with QA Management to ensure Investigations, CAPAs, and Complaints are… more
- PCI Pharma Services (Philadelphia, PA)
- …to pioneer and shape the future of PCI. The **Quality Systems Manager ** is responsible for overseeing and maintaining the Electronic Quality Management System ... Deviations, Change Controls and Corrective and Preventative Actions (CAPA). The Manager will also drive initiatives to analyze quality data, identify trends,… more
- ThermoFisher Scientific (Millersburg, PA)
- …technological innovation, and support patients in need. **Position Summary:** The Manager of Quality Engineering drives day-to-day activities within and is ... division leadership + Help sites prepare for, and actively support, external audits (customer & regulatory) ensuring corrective/preventative actions are put in place… more
- BioLife Plasma Services (Camp Hill, PA)
- …manufacturing is performed consistently according to current Good Manufacturing Practices ( cGMP ), the Shire Quality System, and other applicable regulations for a ... must also maintain complete and accurate records, in accordance with cGMP . **_ACCOUNTABILITIES_** + **Performs duties associated with** **Quality** **(including but… more
- PCI Pharma Services (Philadelphia, PA)
- …is responsible for providing the direction, organization, alignment, monitoring and cGMP compliance to ensure the successful, cost effective, timely and safe ... processing of customer orders. The position audits production room documentation, sampling requirements, reviews equipment challenges...Must have knowledge of and adherence to all PCI, cGMP , and GCP policies, procedures and rules. + May… more
- PCI Pharma Services (Philadelphia, PA)
- …Responsible for the generation and execution of validation protocols, assistance in audits , and determination of validation needs. This job has no supervisory ... required. 4. Prepares change control and validation history report for audits . 5. Attends conference calls and meetings. Effectively communicates project goals… more
- Grifols Shared Services North America, Inc (Williamsport, PA)
- …Performs documentation review for unsuitable test results. * Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements ... Systems Associate** Summary: Under the direct supervision of the Quality Systems Manager , perform quality assurance and Training functions to ensure compliance with… more
- CSL Plasma (Philadelphia, PA)
- **The Opportunity** This position provides immediate support to the Assistant Manager of Quality in monitoring plasma center processes to ensure overall compliance ... the development and implementation of continuous improvement plans + Collaborate with Assistant Manager of Quality (AMQ), to be able to represent the center during… more
- Merck (West Point, PA)
- …with all cGMP , safety, and environmental regulations. - Participates in audits and training programs in the area of responsibility. In accordance with Policy ... working with independent judgment and minimal supervision, and serving in the Manager 's absence as delegated. - Maintains an effective organization via appropriate… more