GCP QA Auditor

About the position

The GCP QA Auditor position at Medpace is a critical role within the Quality Assurance department, responsible for supporting and auditing global clinical trials across various therapeutic areas. The role ensures compliance with organizational and regulatory standards, contributing to the overall success of the QA team. The auditor will lead quality programs, develop audit strategies, and conduct both internal and external audits, playing a vital part in maintaining high-quality standards in clinical research.

Responsibilities
? Act as a Quality Program Lead on clinical trials by supporting national and international regulatory standards and guidance for pharmaceuticals, biologics, and medical devices.
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? Develop audit management plans and audit strategy with clients for ongoing clinical trials.
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? Coordinate and conduct internal system audits and external investigative site/vendor audits in accordance with Good Clinical Practice (GCP) guidelines.
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? Participate in the development of departmental standard operating procedures, work instructions, forms, and templates.
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? Assess validated state and security of proprietary and cloud-based software.
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? Develop training materials and applicable interactive tests and proficiency training including company-wide regulatory training (ICH/GCP).

Requirements
? Bachelor's degree in life sciences or related field;
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? 2-5 years of experience in a QA department in a related industry;
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? Experience conducting audits of vendors and investigative sites;
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? Experience hosting regulatory authorities and interacting with sponsor/client representatives;
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? Independent thinking and planning ability;
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? Knowledge and application of Good Clinical Practice (GCP) is required;
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? Medical Device and or Phase 1 experience is a plus;
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? Ability to travel up to 30%-40% of time;
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? Excellent written and verbal communication skills;
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? Exceptional teamwork skills; and
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? Ability to work independently.

Nice-to-haves
? Medical Device and or Phase 1 experience is a plus.

Benefits
? Hybrid work-from-home options (dependent upon position and level)
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? Competitive PTO packages, starting at 20+ days
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? Competitive compensation and benefits package
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? Flexible work schedule
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? Company-sponsored employee appreciation events
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? Employee health and wellness initiatives
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? Community involvement with local nonprofit organizations
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? Discounts on local sports games, fitness gyms and attractions
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? Modern, ecofriendly campus with an on-site fitness center
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? Structured career paths with opportunities for professional growth
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? Discounted tuition for UC online programs

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