*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.
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
Conduct inspection(s) during the active testing portion of each
Determine that no deviations from approved protocols or standard
operating procedures were made without proper authorization and
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
Conduct internal quality system audits and report findings to
Work with management to implement and improve QA process
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
Train and communicate findings and recommended actions to study
directors and management
Maintain a safe, fast-paced, and positive laboratory
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
Experience with EPA/FDA Good Laboratory Practice (GLP)
regulations (40 CFR Part 160 and 21 CFR part 58)
. 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
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
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