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.

The work schedule for this position will be Monday - Friday 8:00am to 4:30pm

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.

Required Education/Degree:

• Bachelor's Degree in a Life Science field of study or a related scientific field

• Required Certification/License: N/A

Required Work Experience:

• Relevant QA/QC experience in pharmaceutical/biotech/laboratory industry or working knowledge of GxPs or FDA regulations.

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!

Starting pay is $20/hr. Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits including: Medical, Dental, Vision, Life, 401(K), Paid time off (PTO) or Flexible time off (FTO), Company bonus where applicable.

Labcorp is proud to be an Equal Opportunity Employer:

As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, age, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.

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