Our Duluth, GA client is in need of an eCompliance/Quality Metrics Specialist to facilitate and support the definition, implementation and monitoring of computerized systems. The role has authority to approve CSV process, and provide an independent oversight to minimize the Company’s risk exposure in compliance with applicable laws, regulations, policies and procedures (Global and Site). In addition, this role will assist in the development of metrics to measure growth, provide guidance for analysis design and review protocols/statistical methods.

Major Accountabilities include:
Determine the need for complementary policy, standards, guidelines or other documents in order to develop specifically particular CSV requirements where necessary.
Assess compliance against this standard and any associated CSV standard or guideline through audit or other means, as appropriate.
Support the determination of the GxP status of the computerized system and completing assessment/remediation plans from compliance gaps.
Approve relevant validation deliverables and review implications arising from changes to computerized systems.
Ensure that periodic reviews, inventories and remediation actions of computerized systems are properly maintained.
Provide technical, analytical and statistical support for appropriate metric development.

Desired Skills & Experience:
Minimum Education Required:
BS Engineering, IT, Physical Sciences, or equivalent education and experience. MS Engineering or Physical Sciences preferable. ASQ Certification as a CQA, CQE, CQT or equivalent. Six Sigma Certification or equivalent. 6+ years QA or validation experience with FDA Quality System Regulations, ISO, MDD and other international healthcare regulatory requirements preferred.

Minimum Experience Required:
Manufacturing QA experience or a minimum of 3 years manufacturing/technical experience in a pharmaceutical or FDA and GMP regulated environment. Experience with all phases of computerized system (software and infrastructure) validation and qualification. Thorough knowledge of ISO, cGMP’s , GLP’s, 21 CFR Part 11 and 820 requirements.

Please visit us on the web at www.frontlinesourcegroup.com

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Equal Opportunity Employer, M/F/V/D.  Candidates must have authorization to work in the U.S.  Clients will not sponsor visas.

Frontline Source Group™ is one of the fastest growing Information Technology, Accounting, Legal, Human Resources, Administrative, and Clerical staffing and direct hire firms with offices throughout Texas (Arlington, Austin, Dallas, Fort Worth, Plano, Houston Galleria, Lewisville, West Houston, San Antonio, Sugar Land, and The Woodlands), Tennessee (Nashville and Brentwood), and Arizona (Phoenix and Scottsdale).

Frontline specializes in matching top talent with companies for direct, contract, and contract-to-hire placements.  We work with clients and candidates in all areas of the United States and Canada.