Job Description

The Quality Assurance Officer/Safety Officer will function collaboratively within the company in two roles as the Technical Supervisor as defined by CLIA/CAP/FDA GMP regulations and as the Safety Officer administering the Safety Program at Diatherix.  As the Quality Assurance Officer, they will be responsible for designing, implementing, enforcing, monitoring, maintaining and revising Quality Assurance activities throughout the Diatherix operations. In the role of the Safety Officer, they will maintain all safety standards required for staff and laboratory personnel, comply with any OSHA regulations, administer Worker’s Compensation in conjunction with the Human Resources department, and comply with any other required state or federal regulations.  They will also serve as the subject-matter-expert in both the CLIA/CAP/New York State clinical laboratory regulations and safety areas and provide employees with any needed education or assistance in meeting compliance standards.

QUALITY MANAGEMENT SYSTEM

• Ensures that the laboratory is in compliance with pertinent regulatory requirements (i.e. CLIA, CAP, and New York State etc., as applicable). through the administration and maintenance of the clinical laboratory Quality Management system.
• Guide and assist the appropriate departments in preparation for inspections and to maintain continual “inspection readiness” including but not limited to CLIA, CAP, New York State and related audits.
• Maintain and monitor proficiency testing. Provide specific or generalized summary of proficiency testing trends, issues and failures to the Laboratory Director.
• Develop and maintain company audit plans and schedules
• Lead regulatory agency inspections as well as formal responses to their findings/recommendations.
• Provide training to site employees in Inspection Readiness activities and regulatory guidelines (i.e. preparation and conduct during regulatory inspections).
• Develop and facilitate the ongoing maintenance of the quality assurance program. Collaborate with other managerial personnel in formulating, establishing, and maintaining the company quality policies and standard operating procedures.
• Engage in the regular monitoring of Clinical Quality Control and Quality Assurance Data. Interact with Research and Development, QC, Production, and Document Control to assemble the appropriate materials that will facilitate the active review of these data in compliance with established CLIA, CLSI, CAP, and other applicable guidelines.

PROCESS IMPROVEMENT

• Initiate, lead and maintain process improvement activities with the multidisciplinary groups of the Diatherix organization 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.
• Assess current quality assurance standards, existing company quality policies and procedures to evaluate the effectiveness of the quality assurance program in order to determine areas of improvement to ensure compliance with regulatory requirements.

Identify areas of “quality weakness” and develop process improvements to insure quality results.

• Engage in site investigations in order to mitigate any quality-related issues and in identification of new quality improvements.
• 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 Clinical 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 and post-analytical processes
• Initiate corrective actions in concert with the management team

DOCUMENT CONTROL

• Oversee organizational facilities management to ensure that a system of archiving facilities documents and project study files is in place and is secure as expected by pertinent regulatory requirements and good practice standards, as required.
• Approve method validation protocols, validation reports, test methods, general laboratory protocols and standard operating procedures to assure regulatory compliance.
• Supervise and manage the Quality department staff to ensure the SOP revision and distribution process is performed according to established timelines, guidelines and procedures, including document control standards and electronic filing.
• Serve as backup for file maintenance

TRAINING AND EDUCATION

• Develop and oversee training programs and training effectiveness, to insure employees work to quality systems required in the areas of all applicable regulations.
• Provide quality and regulatory guidance to personnel on quality related issues.
• As it is related to quality assurance and safety, work together with the Sales Support Supervisor to communicate information between the Clinical Laboratory and Client Services to meet the needs of the Sales and Marketing staff and the clients. This function will include:
• speaking with clients regarding their questions and concerns as they relate to patient testing and results
• coordinate appropriate resources to address questions or problems that are presented by clients
• prepare information related to testing processes, interpretation of results or results data for the Sales Department for educational purposes
• research and document appropriate client complaints along with resolution
• Serve as the subject-matter-expert in CLIA/CAP/New York State, etc. regulations providing education and assistance to employees and departments to meet and maintain compliance
• Provide assistance to Hospital Integration, satellite labs and international laboratories as scheduled by the VP of Operations
• Duties may change as company needs change

SAFETY OFFICER

• Develop standard operating procedures for all staff to support the function and maintenance of the safety program.
• Manage Safety program in accordance with federal, state and local rules and regulations and corporate policies and procedures
• Develop, maintain and ensure appropriate administration of safety education and competency assessment of all laboratory personnel, in conjunction with departmental managers and the Laboratory Director. This may be in the form of policies, procedures, presentations, online course assignments, in-service demonstrations, webinars, etc.
• Document and maintain documentation of all safety training and competency assessments according to all relevant regulatory and operational requirements.
• Maintain safety data sheets (SDS) records on chemicals and compounds used by the laboratory and other divisions
• Conduct risk-based laboratory safety inspections and audits, safety equipment inspections and certifications, exposure monitoring, assist with biological spill clean-up and any other activities associated with hazardous biological materials
• Manage, coordinate and/or perform all activities associated with the Diatherix Safety to support a safe working environment
• Prepare accident/incident reports and maintaining an accident/incident log in accordance with OSHA Regulations
• Administer the Worker’s Compensation program in conjunction with the Human Resources department.
• Serve as the subject-matter-expert in Safety regulations providing education and assistance to employees and departments to meet and maintain compliance

Qualifications

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/EXPERIENCE (BMQ):

• Minimum of a Bachelor’s Degree in microbiology, biology or a related science and Certification by the American Society of Clinical Pathologists (or equivalent).
• Has extensive experience in a clinical laboratory environment that includes routine testing of patient’s specimens and management of hospital or reference laboratory facilities that have been accredited by either CLIA, Joint Commission, or the College of American Pathologists.
• Prefer experience with clinical molecular diagnostics
• Prefer familiarity with pathogenic mechanisms associated with viral, bacterial, and fungal infections and the expertise to effectively communicate test results to the end users (clinical practitioners).
• Proven track record of establishing and managing Quality Management Systems.
• Familiar with OSHA & Worker’s Compensation Regulations

ABILITY AND/OR SKILLS (BMQ):

• Possesses supervisory and managerial skills to provide assistance in a complex clinical laboratory environment.
• Knowledge of regulatory agencies to include CLIA, CAP, FDA and respective laws and guidelines.
• Strong understanding of Quality Assurance practices, systems, and software helpful
• 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.

Additional Information

Day, M-F 8:00 am – 5:00 pm, Full-Time. Candidates currently living within a commutable distance of Huntsville, AL are encouraged to apply.

WHAT WE OFFER:

• Excellent full time benefits including comprehensive medical coverage, dental, and vision options
• Life and disability insurance
• 401(k) with company match
• Paid vacation and holidays

 EUROFINS IS A M/F, DISABLED, AND VETERAN EQUAL EMPLOYMENT OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER.

Eurofins Scientific is an international life sciences company, providing a unique range of analytical testing services to clients across multiple industries, to make life and our environment safer, healthier and more sustainable. From the food you eat, to the water you drink, to the medicines you rely on, Eurofins laboratories work with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labelling is accurate.

The Eurofins network of companies is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. It is one of the market leaders in certain testing and laboratory services for genomics, discovery pharmacology, forensics, advanced material sciences and in the support of clinical studies, as well as having an emerging global presence in Contract Development and Manufacturing Organisations. It also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.

In over 30 years, Eurofins has grown from one laboratory in Nantes, France to 58,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 54 countries. Eurofins companies offer a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.

In 2021, Eurofins generated total revenues of EUR 6.72 billion, and has been among the best performing stocks in Europe over the past 20 years.

EUROFINS IS A M/F, DISABLED, AND VETERAN EQUAL EMPLOYMENT OPPORTUNITY AND AFFIRMATIVE ACTION EMPLOYER.