Q.C. Jobs in Pharmaceutical Industry, USA

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Post Market Quality Assurance Clinician (SCH00168)

Job Summary We currently have an opportunity for a Post Market Quality Assurance Clinician who will provide clinical knowledge, training and evaluation for processing of high risk customer complaints to ensure compliance with all regulatory obligations. Responsibilities •Review customer complaints to identify issues that could potentially impact patient safety. • Serve as the clinical contact to facilitate investigations of potential adverse events between the customers and PMQA. • Assist with determining if an event meets any regulatory reporting requirements such as MDR, ADE or F
Phama Job Categories: 
USA
Quality Control

SR QUALITY ENGINEER

Job Summary This position reports directly to the Manager, QA Critical Systems/Validation and does not have any direct reports. This position is also expected to work in partnership with manufacturing operations, technology transfer, quality control and assurance, engineering, maintenance and support areas to solve problems and provide expertise on compliance issues and corporate quality policy requirements relating to critical systems.
Phama Job Categories: 
USA
Quality Control

COMPUTER SYSTEMS SPECIALIST

Job Summary The Computer Systems Specialist will be responsible for meeting quality, regulatory, and customer requirements associated with the implementation and maintenance of computerized systems at Fresenius Kabi USA, LLC. The Computer Systems Specialist will partner with the IT organization and computer system owners to ensure Fresenius Kabi USA computer system compliance requirements are followed to support the operation of multiple computerized systems. Responsibilities Administers, coordinates, performs, and assists in the management of computerized system life cycle documen
Phama Job Categories: 
USA
Quality Control

Global Quality Auditor (SCH00152)

Job Summary This position is located in our corporate office in Lake Zurich, IL however the candidate will have an option to be located in Bad Homburg, Germany Responsibilities We currently have an opportunity for Global Quality Auditor to join a newly formed Global Audit team. The position will be responsible for performing inspectional audits across the world of our Manufacturing, Services, Sales and Marketing, and R&D sites.
Phama Job Categories: 
USA
Quality Control

SR QA SPECIALIST

Job Summary Responsible for working with FK USA Contract Manufacturers and internal personnel for batch record review, compilation, and disposition of product batches. Confirms compliance with cGMPs, SOPs, DEA and FDA regulations, as well as applicable Quality Agreements with CMOs. The Senior QA Specialist shows leadership and direction over CMO relationships toward compliance to cGMPs and Quality Agreements.
Phama Job Categories: 
USA
Quality Control

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