Quality Assurance Manager

2 weeks ago

Chicago, United States Grnalbuquerque Full time

Quality Assurance Manager Hoffmann Estates, IL

Required Experience: 5+ years working in a GLP regulated environment 5+ years working in a GLP regulated environment Supervisory/Management experience preferred Required Education: Bachelor’s Degree (M.S. degree preferred)

Job Description

The Quality Assurance Manager is responsible for coordinating Global Quality Standards and Practices, providing leadership in the development and implementation of an independent quality system to support bioanalytical lab operations. They will proactively identify areas of regulatory risk and bring those items to the attention of lab management and senior leadership. Duties/Responsibilities: • Lead a highly effective QA team to ensure lab operations comply with GLP requirements. • Develop and execute training for all Company employees on quality assurance policies, programs, and initiatives and GLP regulatory requirements. • Ensure that documents are reviewed and processes completed in accordance with company quality policies and procedures and in compliance with GLP. • Write, review, and approve (where applicable) procedures and quality documentation. • Conduct review of study data and final reports, in support of regulatory submissions. • Mentor Quality Assurance Team and monitor new development of regulations. • Serve as a source of QA advice and guidance to Company personnel, answer questions regarding QA procedures and training, and provide a source of advice on GLP requirements. • Conduct review and sign-off on study plans and schedule inspections. • Conduct final report reviews and data audits in order to assure that the report is an accurate reflection of the methods used and raw data generated during the study and that the data are compliant, then report any review findings to relevant personnel. • Conduct and report on quality system audits (internal and vendor). • Create, review, control, and/or approve documents required for GLP compliance. • Assist management with awareness of compliance issues and appraise management of audit findings, initiating discussions with appropriate personnel as necessary. • Assist with preparation, conduct and response to customer and regulatory agency requests and inspections. • Responsible for Quality aspects of Sponsor visits/audits and preparation/issuance of report for such visits/audits, ensuring completion of any actions. • Review site quality policies and procedures and ensuring content consistency of standards with GLP requirements, and present recommendations and changes to management. • Oversite of controlled document system. • Provide training in GLP for Bioanalytical department and support departments (where applicable). • Maintenance of the final report audit schedule. • Sign off Training records for QAU personnel. • Coordinate Global Quality standards and practices. • Assume other activities and responsibilities as assigned.

Knowledge & Skills

• 5+ years working in a GLP regulated environment with 2+ years in a quality assurance or related roles. • Bachelor’s Degree (M.S. degree preferred), plus industry (pharmaceutical or bio lab) experience and/or equivalent. • Solid understanding of FDA regulations relating to GLP. • Sound understanding of quality systems pertaining to contract research supporting Pharmaceutical industry and good documentation practices, preferably within the CRO, life science, or pharmaceutical industry. • Excellent computer skills; Word, Excel, PowerPoint and need to be adept at learning new systems. • Ability to handle confidential information with organizational skills for filing and file maintenance. • Ability to prioritize and complete work in a timely fashion and demonstrate attention to detail. • Be pro-active and demonstrate initiative. • Team player and experience of dealing with complex tasks. • Demonstrated effective oral and written communication skills and excellent interpersonal skills; ability to deal with people at all levels. • Time-management skills are required, as well as the ability to handle multiple projects.

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