Laboratory Quality Analyst #21-93103
Regular, full-time or part-time employees working 20 or more hours per week are eligible for comprehensive benefits. Click here to see benefits highlights.
Colorado Coagulation, part of LabCorp Specialty Testing Group, is seeking a QA Analyst to work in our laboratory 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.
The Quality Assurance team provides vital support to the laboratories, senior management as well as our clients, and other LabCorp sites. The QA Analyst will be responsible for supporting projects and activities as they relate to quality assurance, quality control, quality improvement, quality training, and other responsibilities of the Quality Assurance department. This position will be supporting both the clinical laboratory and clinical trials department for all QA related activities.
The schedule for this position will be: Monday — Friday, 8:00am-5:00pm.
- Bachelor’s Degree in a Biology, Chemistry or similar life science field of study required
- 1-2 years of previous experience in a clinical laboratory as a Technologist or Technician OR 1-2 years of quality related experience within a regulated environment, such as pharma or biotech industry
- Previous experience with an electronic data management system is a plus (i.e. MasterControl)
- General knowledge of laboratory regulations (CAP/CLIA/ISO) and licensing requirements
- Strong understanding of audit-related requirements and procedures
- Working knowledge of quality assurance/quality management best practices
- Excellent analytical, critical thinking and problem-solving skills
- Strong communication skills; both written and verbal
- High level of attention to detail with strong organizational skills
- Ability to work independently and within a team environment
- Strong computer skills with proficiency with MS Office programs
1st shift (Monday-Friday 8:00am-5:00pm)
- Coordinates and tracks timely reporting of internal and external proficiency testing results, maintains accurate records of handling, reports and follow up
- Schedules and conducts regular QA audits and inspections of assigned departments and facilities as well as participates in external audits and inspections
- Maintains document control system, CQI and training to assure consistency of applications and procedures
- Reviews monthly quality control data for trends, problems and accuracy of data and works with appropriate departmental supervisors to troubleshoot, resolve issues and provide corrective action
- Assists in establishing and reviewing validation protocols
- Keeps QA Manager informed of any significant issues affecting overall laboratory quality including but not limited to audit findings, validations, corrective and preventative actions
- Works with department supervisors to assure new procedures are appropriately implemented and documented
- Prepares filing for necessary licensure, certification and/or accreditation as appropriate for the laboratory’s test complexity
- Implements policies with respect to CLIA regulations, CAP accreditation FDA compliance, and/or specific state regulations, providing organizational tools, e.g., forms, guidelines, consultation assistance
Starting pay is $50,000/year. 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.