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19 days old

Quality Assurance Supervisor

Kelly Services
Gaithersburg, MD 20898
Kelly Services is actively recruiting for a Quality Assurance Toxicology Supervisor in Rockville, Maryland. This is a Direct Hire Opportunity!


The QA Supervisor will coordinate auditing activities as related to:


+ Biotherapeutics in an FDA regulated facility

+ GeneTox assays including but not limited to:

+ AMES assay

+ In vitro chrom aberration/Micronucleus/comet assays in cell lines and primary human peripheral blood lymphocytes

+ In vitro mammalian Mutation in various cell lines

+ In vivo rat/mouse Micronucleus/comet assays

+ Any other IND-enabling mechanistic assays conducted in support of issue resolution, for example

+ In silico assessment of genotoxic alerts based on various software

+ Ensures site compliance with US FDA and EMA GLPs and other regulatory requirements, including other guidance and publications

+ Reviews and maintains up-to-date Standard Operating Procedures (SOP).

+ Participate in client audits and regulatory inspections

+ Coordinates all QA functions including audits of ongoing operation processes, protocol review, data, study reports and general study compliance with regulatory requirements and SOPs.


Requirements of the Quality Assurance Supervisor includes:


+ BA/BS in science related discipline

+ +5 years of direct bioanalytical auditing experience.

+ Supervisory experience required.

+ Excellent written and verbal communication skills.

+ Excellent time management skills

+ Full understanding of pharmaceutical federal regulations (i.e. GLP, GCP)

+ Experience on the implementation of guidance documents applicable to bioanalysis and pharmaceutical analysis

+ Experience auditing chromatographic data, laboratory LIMS and practices

+ Experience in the implementation of FDA 21CFR11, 21CFR312, 21CFR320 requirements.

+ Bioanalytical experience under FDA, EMA. ICH and other applicable guidelines.

+ Experience in the preparation and implementation of SOPs, protocols, and other documents in accordance with FDA national regulations.

+ Experience in the preparation, approval and tracking and trending of deviations, project investigations, CAPA.

+ Ability to streamline and coordinate local quality processes.

+ Experience managing regulatory and sponsor audits, respond to customer and regulatory audits and follow-up on observations and identified corrective or preventative actions.

+ Able to select, understand and validate 21 CFR part 11 compliant software.

+ Ability to keep abreast of new rules, guidance, and industry standards to improve laboratory compliance.

+ Quality management experience in the pharmaceutical industry preferred.


\#TJP2022_SPEC



**You should know:** Your safety matters! Vaccination against COVID-19 may be a requirement for this job in compliance with current client and governmental policies. A Kelly recruiter will confirm and share more details with you during the interview process.


**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 ?). 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)
Posted: 2022-05-06 Expires: 2022-06-06

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Quality Assurance Supervisor

Kelly Services
Gaithersburg, MD 20898

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