Quality Documentation Specialist/Technician
- Englewood, CO
Colorado Coagulation, part of LabCorp Specialty Testing Group is seeking a Quality Documentation Specialist/Technician to work in its Clinical Trials department in Englewood, CO! Colorado Coagulation is an internationally recognized leader in the field of hemostasis. Our commitment to superior service and quality ensures that we provide our clients with the accurate results and scientific expertise to make informed decisions towards patient care. We are seeking highly motivated, quality-driven individuals who are looking for an opportunity to receive in depth training in the constantly evolving, highly specialized field of hemostasis. Enjoy benefits frequently not available in the health care setting: a low employee-to-supervisor ratio; paid time off for six recognized holidays; limited to no regular scheduling on weekends; and an extensive benefits package.
We are seeking a Quality Documentation Specialist/Technician to join our team. This position will review core and clinical trials project related assay documentation.
The schedule for this position will be: Monday -- Friday, 8:00am - 4:30pm
- 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.
- 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.
- Bachelors Degree in a Life Science or related field of study
- Prevous QA/QC experience in pharmaceutical/biotech/laboratory industry or working knowledge of GLPs or FDA regulations preferred
- Proficient with computers; Familiarity with laboratory information systems are a plus
- High level of attention detail along with strong communication and organizational skills
- Ability to work independently
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!
Monday - Friday, 8:00am - 4:30pm
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