Overview*** This position will specifically focus on clinical laboratory testing within the Unified Women’s Healthcare laboratories ***
The Quality Specialist plays a vital role in the operations of the clinical laboratories in states where Unified Women’s Healthcare has laboratories under the direction and guidance of the Vice President of Laboratory Operations. The Quality Specialist will champion various aspects of the Quality Management Program such as facilitating resolution of non-conforming event management, ensuring compliance with regulatory requirements, and harmonizing practices amongst all Unified Laboratories.
Responsibilities- Supports development, implementation, and monitoring of improvements to the Quality Management System.
- Provides support to regional laboratories in proactive resolution of quality issues and complaints, root cause analysis and troubleshooting as well as CAPA determinations for nonconforming events and follow-up.
- Aids in planning and preparing for state, federal, and CAP accreditation inspections and assists with inspection readiness efforts.
- Drafts various SOPs and other documents and provides training to appropriate staff.
- Performs administrative functions in the laboratories’ electronic Document Control System in MediaLab.
- Coordinates document control activities and documentation of staff training.
- Assists with coordination of Proficiency Testing program for each laboratory.
- Conducts internal quality audits and documents findings.
- Aids with standardizing process, practices and documents across all laboratories.
- Stays up to date on regulatory requirements and guidance and enhances and maintains a company knowledge of relevant regulations and guidance (CAP, CLIA, CLSI, OSHA, HIPAA, etc.).
- Assists in developing and maintaining laboratory-based metrics to measure efficacy of the QMS (e.g., status of document control, employee training, quality audits, corrective actions) and provides visibility for management oversight.
- Delivers presentations in a professional manner with all levels of staff.
- Ensures quality and compliance procedures are followed across all laboratories.
- Maintains effective working relationships and communication across all the Unified Laboratories.
- Follows all company safety policies & other safety precautions within the work area.
- Performs other quality assurance tasks as assigned by manager.
Qualifications- The ideal candidate will have testing or extensive quality experience in microbiology, chemistry, hematology, immunology, and blood bank.
- Bachelor’s degree with a preferred emphasis in medical technology, chemical, or biological science.
- One or more years of clinical laboratory experience with knowledge of CLIA regulations, CAP requirements, and CLSI guidelines is preferred.
- Knowledge of applicable regulatory and accreditation standards, rules, and guidelines.
- Strong skills for organization, planning, decision-making, and facilitating process improvement.
- Exceptional communication skills / professional presence with ability to lead and drive change.
- Strong customer orientation and ability to foster long term customer relationships
- This is a remote position that requires onsite visits for training, audits, and inspections.
- Ability to travel minimally, including overnight visits.
- Ability to create and maintain trend charts supporting, monitoring, and measuring activities.
- Extremely detail oriented and committed to high quality.
- Experience working in a fast-paced laboratory environment.
- Hands-on experience with MediaLab is a plus.
- ASCP certification as a medical technologist is preferred.
- Audit experience and certification are advantageous, such as ASQ or Six Sigma.
