CLT - Clinical Lab Quality Control Technician: Documentation Specialist - Days

LabCorp wants to speak with you about exciting opportunities to join our team as a Quality Control Technician in Englewood, CO.  In this position you will work in a fast paced, customer focused, and challenging environment, and will be a part of our overall mission at LabCorp: "Improving Health, Improving Lives".

Provides support in the secondary review of core and clinical trials project related assay documentation and raw data for accuracy, completeness and compliance with internal processes and procedures.

Application Window: 09/05/2024 – 09/16/2024

Scheduled Days: Monday - Friday

Scheduled Shift Time: 9:00am to 5:30pm.

Job Duties/Responsibilities:

• Reviews checklists for clinical trials data generated by technical staff for accuracy and completion of documentation, including review of supportive documentation as needed to ensure compliance with internal processes.
• Provides review of QC change documentation generated by the QC lead.
• Reviews data generated in study specific templates or spreadsheets used by technical staff to include check of manual calculations if applicable.
• Assists in study test set up in laboratory information system test code submission, sample requirements and/or review of data elements for submission.
• Reviews study documentation binders to ensure proper documentation is in place during feasibility, validation and phase I-III studies (checklists, etc).
• Notifies management of discrepant data or deviations observed in data review for clinical trials documents and assists with investigation and assigning root cause for deviations from internal procedures.
• Communicates with laboratory technical staff to ensure data review findings are concurrent with established SOPs and proper documentation procedures.
• Documents all activities as necessary including preventative maintenance logs, instrument function checks, troubleshooting, and quality control to ensure regulatory compliance.
• Adheres to the standard operating procedures and safety requirements of Labcorp, CLIA, CAP, ICH GCP, and other regulatory bodies.

Requirements:

• Bachelor’s degree in a Chemical or Biological science, Clinical Laboratory Science, Medical Technology or meet local regulatory (CLIA & State) requirements
• Previous clinical laboratory testing experience is highly preferred
• Relevant QA/QC experience in pharmaceutical/biotech/laboratory industry or working knowledge of GxPs or FDA regulations is preffered
• ASCP or AMT certification is preferred
• Ability to work independently and within a team environment
• Proficient with computers; Familiarity with laboratory information systems is a plus
• High level of attention detail along with strong communication and organizational skills
• Must be able to pass a standardized color vision screen
• Flexibility to work overtime or other shifts depending on business needs

Benefits: All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, STD/LTD, 401(K), ESPP, Paid time off (PTO) or Flexible time off (FTO), Commissions, and Company bonus where applicable.  For more detailed information, please click here. 

If you're looking for a career that offers opportunities for growth, continual development, professional challenge and the chance to make a real difference, apply today!

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, Labcorp strives for diversity and inclusion in the workforce and does not tolerate harassment or discrimination of any kind. We make employment decisions based on the needs of our business and the qualifications of the individual and do not discriminate based upon race, religion, color, national origin, gender (including pregnancy or other medical conditions/needs), family or parental status, marital, civil union or domestic partnership status, sexual orientation, gender identity, gender expression, personal appearance, age, veteran status, disability, genetic information, or any other legally protected characteristic.

We encourage all to apply

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