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10 days old

Quality Assurance Manager, Clinical Laboratory

Kelly Services
Long Island City, NY 11101
**Kelly Science and Clinical** is the worlds most recognized brand in science and clinical staffing with more than 100 locations in North America, Europe, and the Pacific Rim. Our scientists contribute to the research and development of the next generation of small molecule drugs, biologics and cellular therapies.


**Overview**


The Quality Assurance Manager is responsible for managing all aspects of the quality of the clinical section of the lab, ensuring that the lab is always in compliance for New York State and CAP inspections.


**Responsibilities**


+ Applies GMP/GLP in all areas of responsibility, as appropriate.

+ Monitor laboratory compliance with respect to expired reagents, reagent labeling, lab cleanliness, training records, PPE adherence, and other cGXP items, as needed to help minimize laboratory audit findings.

+ Perform/Support Internal audits, as well as help, implement the resolution of internal/external audit findings.

+ Review Instrument qualifications to ensure that work is performed as per the procedure

+ Review GLP data for adherence to GLP regulations.

+ Review and verify invalid data and system suitability failures.

+ Review and close Exceptions under Non-Routine Events, System Suitability Failure, and Deviations.

+ Approve Analytical Method/Protocol/SMIS/Client Parameter per QA procedure

+ Track and Analyze quality metrics (exception rate, rejection rate etc) and train laboratory personnel, as needed, to help reduce/eliminate rework.

+ Support other QA compliance-related activities, as needed.

+ Communicate in writing and in person with laboratory personnel in an intelligent and clear manner.

+ Diagnose problems, solve simple problems, and suggest solutions to complex problems in the professional area.

+ Keep oneself and peers abreast of current developments and trends in the professional area by reading and understanding internal procedures, attending training sessions, by writing/revising SOPs (as required), and by assisting Group Leader/Principal Specialists in training new employees.

+ May serve as technical advisor for analysts regarding QA/QC of data.

+ Communicate with internal clients to discuss any findings and notify them of any necessary rework or compliance/regulatory concerns.

+ Support other QA compliance-related activities, as needed.

**Qualifications**


Required:


+ A bachelors degree in a related scientific field.

+ A New York State (NYS) Certification in Medical Laboratory Technology or Medical Laboratory Technician.

+ Certification as an MLT or MT from a nationally accredited organization.

+ At least six years laboratory experience with a strong base in technical knowledge of concepts, principles, practices, methodologies, and instrumentation of each discipline of laboratory science and technology in performing complex analytical analysis.

+ Strong organizational and complex problem-solving skills.

+ Ability to institute continuous quality improvement principles to produce the best possible laboratory data.

+ Excellent communications skills and strong computer proficiency.


Preferred:


+ Prior experience in a leadership position for CAP inspections and laboratory compliance.

+ Prior supervisory experience in a laboratory setting.


**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. 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: 2021-02-19 Expires: 2021-03-22

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Quality Assurance Manager, Clinical Laboratory

Kelly Services
Long Island City, NY 11101

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