Quality Specialist

• Implementing and maintaining patient test quality management, Pre- analytical, Analytic and Post analytic processes.
• Conducts periodic audits of the laboratory to ensure compliance of all areas with the policies of the laboratory and reports non-compliance.
• Coordinates inspections by regulatory agencies, such as CLIA/CAP.
• Responsible for maintaining licenses and registrations; facilitating applications and renewals or any other inspection-related activities.
• Coordinates the proficiency testing activities by facilitating the subscription of required proficiency testing materials, ensuring the testing are performed and results are submitted in a timely manner. Ensures that appropriate follow up on corrective action is implemented when test result/s is found unsatisfactory.
• Drafts policies, procedures and forms for laboratory Quality Management System.
• Develops and maintains document workflows for editing, review and approval.
• Conducts training on policies and procedures.
• Monitors QA indicators and establishes criteria for monitoring service.
• Generates reports to track performance and quality improvement. Assists in developing QA plans. Collects and collates data and implements changes to resolve problems. Provides support for the creation of QA reports for
• regulatory agencies. Prepares annual quality assurance report and submits for review.
• Maintains up-to-date knowledge and understanding of requirements and regulations set forth by CLIA and such agencies.
• Enforces the laboratory safety program through training, monitoring and remediation.

• Bachelor's degree in a work-related discipline/field from an accredited college or university.
• Master’s degree in a work- related discipline/field preferred. Five (5) years of progressively responsible and directly related clinical laboratory work experience.
• Knowledge of and understanding of the processes, methods and operations in functional area(s) of responsibility.
• Knowledge of local, state and federal regulatory requirements related to areas of functional responsibility.
• Ability to analyze data, draw conclusions and interpret results.
• Ability to communicate effectively, both orally and in writing.
• Ability to plan, organize, develop tactical plans and set priorities.
• Ability to solve problems and identify solutions.
• Ability to work effectively with individuals at all levels of the organization.

Employee Benefits:  

At LanceSoft, full time regular employees who work a minimum of 30 hours a week or more are entitled to the following benefits:  

• Four options of medical Insurance
• Dental and Vision Insurance
• 401k Contributions
• Critical Illness Insurance  
• Voluntary Permanent Life Insurance  
• Accident Insurance
• Other Employee Perks

LanceSoft is a certified Minority Business Enterprise (MBE) and an equal opportunity employer. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.  
This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. LanceSoft makes hiring decisions based solely on qualifications, merit, and business needs at the time.