Work ScheduleStandard (Mon-Fri)
Environmental ConditionsOffice, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)
Job DescriptionThis is a fully remote role supporting our Global Central Laboratory in Highland Heights, KY. We welcome applicants from all locations within the US.
- Must be legally authorized to work in the United States without sponsorship.
- Must be able to pass a comprehensive background check, which includes a drug screening.
DESCRIPTIONHow you will make an impact:
As a Laboratory Quality Specialist III, you will play a critical role in protecting the quality and integrity of laboratory testing performed within our Global Central Laboratory (GCL) operations. You will lead complex quality investigations, evaluate laboratory processes and assay-related documentation, determine true root causes of quality events, and partner across laboratory, quality, and business teams to implement sustainable corrective and preventive actions (CAPAs).
In this role, you'll help ensure laboratory processes, assays, and quality systems continue to meet the rigorous standards required under CAP (College of American Pathologists) and CLIA (Clinical Laboratory Improvement Amendments) accreditation, as well as applicable regulatory and client requirements. Your work directly supports the delivery of reliable laboratory data used by pharmaceutical and biotechnology customers to advance clinical research and drug development.
This position is ideal for a laboratory quality professional who combines strong scientific knowledge with exceptional investigation, analytical thinking, and problem-solving skills.
What you will do:- Lead complex quality investigations to determine true root cause of laboratory quality events, deviations, documentation issues, and assay-related concerns.
- Collaborate with laboratory operations, quality teams, and cross-functional stakeholders to develop, implement, and monitor the effectiveness of Corrective and Preventive Actions (CAPAs).
- Provide technical guidance and mentoring to junior investigators and quality personnel on investigation methodologies, root cause analysis, and quality documentation.
- Deliver training to quality record authors and approvers to promote consistent application of Standard Operating Procedures (SOPs) and investigation best practices.
- Support internal audits, client audits, regulatory inspections, and sponsor inquiries as needed.
- Perform complex database and quality review of laboratory data, MTM content, source documentation, validation documents, SOPs, and supporting records.
- Support change control review and impact assessment, including evaluation of downstream impacts to reporting, study setup, MTMs, DSR-related content, calculations, Tox Grades, LOINC, UOM, custom reference ranges, and custom alerts.
- Review laboratory quality records, investigation reports, analytical and bioanalytical reports, and supporting documentation for technical accuracy, completeness, and compliance with internal procedures and regulatory expectations.
- Participate in investigation and resolution of quality events, escalations, documentation gaps, and database content questions.
- Draft and review internal and external communications related to change controls, custom reports, UOM requests, LOINC, pediatric or custom reference ranges, custom alerts, and other business needs.
- Evaluate laboratory trends, quality metrics, and recurring issues to identify opportunities for continuous improvement.
- Support CAP and CLIA accredited laboratory operations by ensuring investigations and documentation meet applicable quality standards.
- Enter, maintain, and reconcile data in laboratory databases, tracking tools, metrics repositories, and related business applications.
- Partner with laboratory leadership, assay development, validation, and operational teams to resolve complex quality issues and support process improvements.
- Support toxicity grading version updates, master tox table revisions, coding QC, tox grade output verification, and implementation timelines.
- Serve as a quality representative on cross-functional projects involving laboratory quality systems, assay implementation, and operational improvements.
- Train or support onboarding of Business Transformation, QIS, MTM, or other global staff on relevant database and quality processes.
REQUIREMENTSKeys to Success:
Education:
- Advanced degree plus 3 years of experience, or Bachelor's degree plus 5 years of experience in quality assurance, quality control, laboratory operations, clinical research, regulated data review, or a related technical field.
- Preferred fields of study: Life Sciences, Chemistry, Biology, Medical Laboratory Science, Engineering, Regulatory Science, or related technical field.
Experience:- Experience conducting complex quality investigations and performing root cause analysis.
- Experience developing and implementing CAPAs.
- Experience with change control, quality investigations, technical documentation review, analytical data/report review, laboratory database review, or related quality processes.
- Experience working in regulated laboratory environments supporting CAP, CLIA, GLP (Good Laboratory Practice), GMP (Good Manufacturing Practice), GCP (Good Clinical Practice), or other GxP quality systems preferred.
- Experience supporting laboratory accreditation, regulatory inspections, or client audits preferred.
- Experience with laboratory databases, quality systems, document control systems, TrackWise, Preclarus, or similar business applications preferred.
Knowledge, Skills, Abilities:- Strong understanding of laboratory operations, quality systems, and regulated documentation practices.
- Demonstrated expertise in root cause analysis, investigation techniques, and quality decision-making.
- Experience reviewing laboratory assays, assay validation documentation, analytical data, or laboratory quality records.
- Excellent analytical and critical thinking skills with the ability to identify trends, assess risk, and develop practical solutions.
- Strong written and verbal communication skills with the ability to clearly document technical investigations and present findings.
- Ability to collaborate effectively across laboratory operations, quality, scientific, and business teams.
- Strong organizational skills with the ability to manage multiple priorities in a fast-paced environment.
- Proficiency with Microsoft Office applications and electronic quality management systems.
Working Conditions and Environment:- Exposure to high pressure, intense concentration needed.
- Must pay constant attention to detail-visual, mental.
- Must be able to multi-task constantly.
- Frequent interaction with clients and associates required.
- Long, varied hours required occasionally.
- Travel and rotating shifts required on rare occasions.
- Exposure to toxic materials on rare occasions.
Physical Requirements:- Frequently stationary for 6-8 hours per day.
- Repetitive hand movement of both hands with the ability to make fast, simple, repeated movements of the fingers, hands, and wrists.
- Frequent mobility required.
- Occasional crouching, stooping, bending and twisting of upper body and neck.
- Light to moderate lifting and carrying (or otherwise moves) objects including luggage and laptop computer with a maximum lift of 15-20 lbs.
- Ability to access and use a variety of computer software developed both in-house and off-the-shelf.
- Ability to communicate information and ideas so others will understand; with the ability to listen to and understand information and ideas presented through spoken words and sentences.
- Frequently interacts with others to obtain or relate information to diverse groups.
- Works independently with little guidance or reliance on oral or written instructions and plans work schedules to meet goals. Requires multiple periods of intense concentration.
- Performs a wide range of variable tasks as dictated by variable demands and changing conditions with little predictability as to the occurrence. Ability to perform under stress. Ability to multi-task.
- Regular and consistent attendance.
