Madison Core Laboratories is a state-of-the-art, full-service independent clinical laboratory. We are passionate about what we do and are dedicated to providing excellent service that will make positive changes in the lives of those we serve. Our facility is in Huntsville, Alabama, which has been named as the Number 1 Best Place to Live by U.S. News & World Report for 2022-2023.
We are seeking a Quality Assurance (QA) Manager to function collaboratively within the Company as the laboratory compliance and quality expert. This position will be responsible for designing, implementing, enforcing, monitoring, maintaining, and revising quality assurance activities throughout the laboratory operations. The QA Manager will also serve as the subject matter expert in both the CLIA/CAP clinical laboratory regulations and provide employees with any needed education or assistance in meeting compliance standards.
Job Status: Full-Time | Exempt | Salaried
Quality Management and Process Improvement
- Ensure that the laboratory is in compliance with pertinent regulatory requirements (i.e., CLIA, CAP, FDA, etc., as applicable) through the administration and maintenance of the Laboratory Quality Management Program.
- Guide and assist the appropriate departments in preparation for inspections and to maintain continual inspection readiness including but not limited to CLIA, CAP, FDA, and related audits.
- Provide training to site employees in Inspection Readiness activities and regulatory guidelines (i.e., preparation and conduct during regulatory inspections).
- Lead regulatory agency inspections as well as formal responses to their findings/recommendations.
- Maintain and monitor proficiency testing. Provide summary of proficiency testing trends, issues, and failures to the Laboratory Supervisors, Laboratory Manager, and Laboratory Director.
- Develop and maintain laboratory audit plans and schedules.
- Develop, facilitate, and maintain the Laboratory Quality Assurance Program.
- Collaborate with other managerial personnel in formulating, establishing, and maintaining the company quality policies and standard operating procedures.
- Monitor Laboratory Quality Control and Quality Assurance Data.
- Prepare quality management reports to share with laboratory staff and leadership.
- Initiate, lead, and maintain process improvement activities in the laboratories to ensure optimal delivery of service that meet quality, cost efficiencies and customer service goals
- Utilize approved Quality Management Systems (QMS) systems to identify and address non-compliance trends.
- Represent the company in regulatory and quality in external regulatory agencies and conferences.
- Ensure company quality policies and procedures are in accordance with current quality assurance standards.
- Utilize quality data to evaluate the effectiveness of the quality assurance program to determine areas in need of improvement.
- Engage in site investigations to mitigate any quality-related issues.
- Review pertinent publications to stay abreast of the regulatory and quality developments within the industry and ensure adherence to highest quality and efficiency standards in laboratory operations.
- As related to quality operations, interact with the laboratory staff as requested to evaluate, respond to, and resolve issues that relate to test performance or the interpretation of test results.
- Participate in the planning and coordination of pre-analytical, analytical, and post-analytical processes.
- Initiate corrective actions with the management team.
- Provide quality and regulatory guidance to personnel on quality-related issues.
- Maintain all laboratory document control processes.
- Serve as MediaLab site administrator over the Document Control, Inspection Proof, and IQE modules.
- Serve as laboratory document control expert and resource for all laboratory departments.
- Review and approve method validation protocols, validation reports, test methods, general laboratory protocols and standard operating procedures to assure quality and regulatory compliance.
- Ensure the laboratory document control and distribution process is performed according to established timelines, guidelines, and procedures, including document control standards and electronic filing.
To perform this job successfully, the individual must be able to perform each essential duty satisfactorily. The requirements below are representative of the knowledge, skill or ability required.
EDUCATION AND EXPERIENCE:
- Minimum of a bachelor’s degree in Medical Technology, Clinical Laboratory. Sciences, chemistry, microbiology, biology, or a related science.
- Certification by the American Society of Clinical Pathologists preferred (or equivalent).
- Has extensive experience in a clinical laboratory environment that includes routine testing of patient’s specimens, quality management, and general laboratory. management of hospital or reference laboratory facilities with accreditation through CLIA or the College of American Pathologists.
SKILLS AND ABILITIES:
- Possess supervisory and managerial skills to aid in a complex clinical laboratory environment.
- Knowledge of regulatory agencies including CLIA, CAP, FDA and respective laws and guidelines.
- Strong understanding of Quality Assurance practices, systems, and software.
- Must be able to multitask and keep up in a fast-paced environment.
- Must work well on your own with minimal supervision.
- Must demonstrate key problem-solving skills: active listening, analysis, research, creativity, communication, dependability, decision making, and team building.
Competitive benefits package including Medical, Dental, Vision Insurance, Life, AD&D, Short and Long-Term Disability, PTO, 401K with match, and Direct Deposit. Compensation commensurate with experience. Bonus is possible. Opportunities for advancement are available.
Background check and drug test required. Equal Opportunity/Affirmative Action Employer/DFWP/Tobacco-Free.
Madison Core Laboratories, LLC is an Equal Employment Opportunity (EEO) and Affirmative Action employer. Applicants receive fair and impartial consideration without regard to race, sex, sexual orientation, gender identity, color, religion, national origin, age, disability, veteran status, genetic data, religion, or another legally protected status. If you need accommodation for any part of the employment process because of a medical condition or disability, please call (256) 850-0075 to let us know the nature of your request.