Clinical Laboratory QA Analyst

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Job description

Clinical Lab Quality Assurance Analyst

Kelly Science and Clinical is the world's 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 Clinical Lab Quality Assurance Analyst supports quality assurance (QA) activities in the Molecular Laboratory Operations (MLO) group with one of our clients, a leading immune medicine biotechnology company in Seattle, WA. The primary function of this role is to coordinate completion of CLIA/CAP/NYSDOH compliance activities and related projects within the high-complexity clinical laboratory.

Responsibilities

• Works with subject matter experts within the clinical laboratory to demonstrate ongoing compliance by compiling, managing, and presenting metrics related to overall laboratory performance, such as daily/weekly/monthly operational metrics, non-conformances, and process improvement efforts
• Develops and refines metrics dashboards for use by MLO management
• Interfaces with MLO staff and the QA team to spearhead nonconformance, CAPA and deviation resolution including assessment of sample impact/risk, blockers and project dependencies, managing personnel follow-up to ensure timely resolution and proper documentation; manages notifications to internal/external partners as needed.
• Analyzes trends in nonconforming events, identifies opportunities for continuous quality improvement, and triggers CAPAs as warranted.
• Facilitates continuous quality improvement initiatives with MLO management and the Quality team
• Works closely with Production Laboratory team managers/supervisors to develop and maintain systems for documenting and monitoring training, competency and continuing education of the laboratory staff; assists managers with tracking, scheduling and documenting as needed
• Manages state licensing (NY, CA, etc.) and CAP accreditation renewals
• Administratively supports regulatory submissions for NYSDOH assay approvals
• Ensures that personnel records for new MLO employees are collected and maintained in document control systems, and completed for annual review by the clinical laboratory director (CLD) per CAP/NY requirements
• Supports metrics gathering and generates presentations for periodic quality assessment of the clinical laboratory by the clinical laboratory director (CLD) as required by CLIA/CAP/NYSDOH regulations; interfaces with QA and MLO team to ensure follow up on corrective actions
• Supports Production team managers/supervisors in other QA initiatives to ensure laboratory compliance with applicable regulations.
• Performs administrative tasks as directed by the Director of Lab Ops Compliance or the Clinical Lab Director/VP of Molecular Laboratory Operations
• Supports the corporate QA team during external audits

Qualifications

Required

• Bachelor of Science degree from an accredited university in a biological related field or the equivalent
• At least two years of experience with CAP/CLIA/NYSDOH regulations or Quality Management Systems in a high-complexity clinical laboratory
• Proficiency in MS Office, particularly Excel and PowerPoint, and routine office software applications such as email
• Ability to follow Good Clinical and Laboratory Practices
• Demonstrated ability to work effectively across functional areas.

Preferred

• At least three years of experience in clinical Quality Management Systems or NGS-based laboratory testing in a high-complexity clinical laboratory
• Prior experience as a medical technologist in and CAP/NYSDOH-accredited laboratory, preferably as a team lead or supervisor
• Ability to troubleshoot problems in a fast-paced dynamic organization
• Previous experience with continuing improvement tools
• High integrity and experience with HIPAA compliance
• Experience with LIMS systems, and web-based applications
• Experience with data gathering systems such as Tableau
• Excellent problem-solving skills
• Results and solution-oriented
• Ability to work both independently and collaboratively
• Excellent organizational and time-management skills
• Superior oral and written communication skills

#TJP2021_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.

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 interests-it's 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.

At Kelly, we're always thinking about what's next and advising job seekers on new ways of working to reach their full potential. In fact, we're 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.

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