Quality Assurance (Qa) Analyst - Clinical Pcr Laboratory

WHAT YOU WILL BE DOING

The Quality Assurance (QA) Analyst is a supportive role within the QA department that assists with planning, implementing, and monitoring the Quality Management System (QMS). The QA Analyst is responsible for ensuring that the laboratory meets quality and productivity standards and complies with all regulatory and safety standards as defined by CAP, JCAHO, CLIA and OSHA.

Essential Responsibilities

• Ensures regulatory preparedness at all times by maintaining procedure manuals, training records, validation documents, personnel records, quality documentation, etc. while adhering to CAP, CLIA, and OSHA standards.
• Maintain procedural manuals in applicable areas of the laboratory.
• Participates in laboratory audits and accreditation inspections, at the capacity requested by QA management.
• Acts as a liaison between all departments in the laboratory (including Pre-Analytic, Analytic, and Post-Analytic) and the QA department to answer quality-related questions, implement policies/procedures, and enforce quality objectives.
• Ensures the Document Control System maintains the integrity and organizational standards set by QA management.
• Executes minor changes to controlled documents (as requested) in the Document Control System.
• Ensures that all equipment, machines, or instruments are maintained, inspected, and calibrated.
• Keeps records of applicable service and maintenance agreements as well as logs, as applicable.
• Executes verification of laboratory documentation (e.g., temperature/humidity monitoring, various logs, etc.) on a routine basis established by the QA department.
• Maintains knowledge of proper specimen collection procedures, including patient preparation, labeling, handling, preservation, processing, preparation, transportation, and storage of specimens.
• Obtains QA documentation and data to assist in the creation of monthly/annual Quality Reports, as well as establish effective systems to monitor accuracy assessments and data quality throughout the laboratory.
• Manages laboratory staff contact information.
• Conducts QA procedures to monitor core performance and notifies QA management and area supervisor of performance issues as the issues develop, and work with the area supervisor to establish a remediation plan.
• Provides orientation/training to all new hires as well as current staff, as needed.
• Participates on subspecialty committees, corporate committees, and regional committees as needed.
• Accepts responsibilities delegated from the QA Supervisor or Director (the QA Supervisor or Director is permitted to delegate responsibilities to the QA Analyst, if the QA Analyst is qualified to perform the responsibility).
• Maintains licensures as applicable and participates in continuing education; ensure staffing does the same.
• Acts as a member of the Safety and QA/PI Committee, attends meetings and implements changes, as needed.

OUR IDEAL CANDIDATE HAS:

• Education: Bachelor's degree
• Experience: 2+ years of clinical laboratory experience (preferably within a PCR/High Complexity Based Lab).
• Knowledge/Skills:
  • Excellent verbal and written communication skills.
  • Ability to create and present presentations to small and large groups.
  • Ability to create and work with statistical data.
  • Proficient in Microsoft Office Products (Excel, Word, Adobe, PowerPoint, etc.)
  • Ability to quickly learn proprietary software programs such as LIS, Media Lab, Asana, etc.
  • Ability to travel to other lab locations 10% of time.

ABOUT OUR CLIENT:

MP's client is the nation's leading PCR-based infectious disease laboratory, advancing healthcare through decentralized patient-directed testing, large-scale surveillance pathogen testing, antimicrobial stewardship, and value-based care programs. In a global environment threatened by growing antimicrobial resistance, rapid diagnoses matter. MP's client sets the pace for industry-leading laboratory operations through unparalleled turnaround time, yielding insights that mobilize accurate clinical decisions. With over 20 years in the clinical laboratory industry, MP's client provides services to over 10,000 clinicians nationwide.

ADDITIONAL INFORMATION:

• Salary Range: $75,000 - $85,000 per year
• Location: Clarksville, IN
• Benefits: Medical, Dental, Vision, and more!
• Shift/Schedule: Monday - Friday, Regular Business Hours