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Document Control Reviewer

Company: Kelly
Location: GEORGETOWN
Posted on: May 3, 2021

Job Description:

*Quality Assurance/Document Review Specialist Direct Hire!*

North Austin, TX

Kelly Science & Clinical is currently recruiting for a QA/Document Review Specialist with commercial testing laboratory. This is a GLP quality assurance position as defined in 21 CFR Part 58 and 40 CFR Part 160. The Quality Assurance Specialist will work as part of a team QA professionals to perform data audits and report reviews for antimicrobial efficacy studies. They will also conduct internal inspections for compliance with study protocols, internal SOPs, and the applicable regulations. Approximately 80% of your time will spent doing desk work, primarily review of study documentation and reports. The other 20% will be spent in the laboratory performing inspections during the active testing portion of the study.

*Job Responsibilities:*

Maintain knowledge of current FDA and EPA GLP regulations

Monitor each GLP and/or ISO 17025:2017 compliant study to assure Management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the regulations.

Conduct inspection(s) during the active testing portion of each GLP study.

Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.

Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the study.

Conduct internal quality system audits and report findings to Management.

Work with management to implement and improve QA process efficiency.

Interact with EPA/FDA as needed in the event of external (regulatory agency) audit.

Write or review Standard Operating Procedures (SOP).

Maintain and improve lab documents and record keeping procedures.

Train and communicate findings and recommended actions to study directors and management

Maintain a safe, fast-paced, and positive laboratory environment.

*Job Requirements:*

Bachelors Degree in related field

Excellent writing and review skills.

Prior experience performing document review or internal audits for a GLP testing lab or other regulated laboratory environment.

Experience with EPA/FDA Good Laboratory Practice (GLP) regulations (40 CFR Part 160 and 21 CFR part 58)

*Work Schedule:*

. Typical work schedule is M-F; 8am-5pm with additional hours and weekends as needed.

*Compensation and Benefits:*

Health insurance benefits and retirement savings plan.

Why Kelly? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire talented people just like you. Every day, we match science professionals with dream jobs that fit their skills and interestsits the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background/education in science, so we know a thing or two about the science market and how to get you noticed.

About Kelly

At Kelly, were always thinking about whats next and advising job seekers on new ways of working to reach their full potential. In fact, were a leading advocate for temporary/nontraditional workstyles, because we believe they allow flexibility and tremendous growth opportunities that enable a better way to work and live (plus, did we mention we provide a ton of [benefits](https://www.mykelly.us/us-mykelly/perks/)?). Connecting great people with great companies is what we do best, and our employment opportunities span a wide variety of workstyles, skill levels, and industries around the world.

Kelly is an equal opportunity employer committed to employing a diverse workforce, including, but not limited to, minorities, females, individuals with disabilities, protected veterans, sexual orientation, gender identity. [Equal Employment Opportunity is The Law.](https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm) ]]

Keywords: Kelly, Georgetown , Document Control Reviewer, Other , GEORGETOWN, Texas

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