Kelly Services Senior QA Associate in North Chesterfield, Virginia
Sr QA Associate, Richmond, VA
MUST HAVE EXPERIENCE CLIA!
Kelly Scientific is currently seeking a Sr QA Associate for one of our top clients in Richmond, VA. This position is responsible for performing regulatory activities, providing analysis and support of the company’s and programs’ compliance activities, and day-to-day administration of compliance issues. The focus of the position is ensuring compliance with all Federal, State, and CLIA rules and regulations (CLIA, GMP, GLP, GCP, EHS, OSHA etc). This is a smaller company and a one person department. As our client grows, this person will grow the group, hire all personnel and be the manager.
Responsible for implementation of new methods and procedures, including electronic training, teaching, and tracking modules to ensure compliance with OSHA, FDA, DEA, CDC, DOT, EPA, CLIA, CAP, Joint Commission, IATA, PHMSA, HIPAA, NRC, ISO rules and regulations.
Execute a signed QA statement on all GLP reports which reflects the fact that (1) the study has been conducted in a GLP compliance manner, (2) an “in phase” (or mid study) audit has been conducted, and (3) a report audit has been conducted.
Oversee license applications, prepare follow up response letters, and modify applications as needed until final approval is received.
Research and interpret regulatory requirements of ventures.
Serve as a lead liaison and on-site coordinator for all non-financial regulatory surveys and inspections. This may include negotiating with regulatory agencies as needed.
BS in Scientific Discipline
5 years of lab experience (Clinical lab)
Strong knowledge of GMP. GLP, GCP requirements
Experience conducting audits and preferably hosting audits as well
Knowledge of and or exposure to EHS requirements (preferred not required)
NOTE: Please apply on-line with your resume in MS WORD format only
Why Kelly ® ?
With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevant projects. Our connections can lead you to innovative scientific pursuits you’ll be proud to help advance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 11,000 scientific professionals last year.
You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place. Let Kelly fuel your career—connect with us today.
AboutKelly Services ®
As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2016 was $5.3 billion. Visit kellyservices.com and connect with us on Facebook , LinkedIn and Twitter .
Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is committed to employing a diverse workforce. Equal Employment Opportunity is The Law. at https://www.dol.gov/ofccp/regs/compliance/posters/ofccpost.htm