Laboratory Corporation of America Quality Control Technician - Colorado Coagulation in Englewood, Colorado
Colorado Coagulation, a business unit of Esoterix and a member of the LabCorp Specialty Testing Group, has established itself as an internationally recognized leader in hemostasis testing. Colorado Coagulation is a designated coagulation laboratory with more than 40 years of experience offering distinctive services with a consultative focus. We are dedicated to maintaining leadership in coagulation testing through continuous scientific research and new assay development. Our extensive test menu and consultative approach provide clients with the resources they need to help predict, diagnose, and manage even the most unusual bleeding and clotting disorders.
Colorado Coagulation is currently seeking a Quality Control Technician to join their team!
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.
Essential Job Duties:
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 LIS/Centerlinx: 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 1-111 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.
Adheres to the standard operating procedures and safety requirements of Esoterix, CUA, CAP and other regulatory bodies.
Documents all activities as necessary including preventative maintenance logs, instrument function checks, troubleshooting, and quality control to ensure regulatory compliance.
Additional duties as assigned.
Bachelor's degree in Biology, chemistry or related life science.
1-2 years of experience working in a lab post academic.
Excellent attention to detail
Ability to work independently
- Relevant QA/QC experience in pharmaceutical/biotech/laboratory industry or working knowledge of GLPs or FDA regulations.
As an EOE/AA employer, the organization will not discriminate in its employment practices due to an applicant's race, color, religion, sex, national origin, sexual orientation, gender identity, disability or veteran status.