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Quality Assurance & Safety Officer
at EAG Laboratories
Job Reference #: 18133
Based in Huntsville, Alabama, Diatherix is a highly-specialized laboratory providing cutting-edge molecular diagnostic testing services to hospitals and physicians using proprietary TEM-PCR™ (Target Enriched Multiplex Polymerase Chain Reaction) technology for precise detection of infectious diseases at high levels of sensitivity and specificity, and at very short turnaround times.
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, and comply with any other required state or federal regulations. They will also serve as the subject-matter-expert in both the CLIA/CAP/FDA GMP and safety areas and provide employees with any needed education or assistance in meeting compliance standards.
Quality Assurance & Safety Officer responsibilities include, but are not limited to, the following :
Quality Assurance Officer Job Duites:
· Lead the quality and regulatory initiative for the company to comply with CLIA, CAP, and FDA GMP Regulations
· Lead implementation of and sustaining GMP in Manufacturing and R&D, as required.
· Assure that the organizational facilities management, through oversight and internal auditing, is in compliance with pertinent regulatory requirements (i.e. CLIA, CAP, and FDA GMP Regulations as applicable).
· Guide and assist the appropriate departments in preparation for inspections and maintaining continual “inspection readiness” including but not limited to CLIA, CAP, New York State, and GMP-related audits
· Develop and maintain company audit plans and schedules
· Coordinate or perform quality assurance system audits of laboratory performance
· 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 QMS systems to identify and address non-compliance trends.
· 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.
· Work with operations and scientific staff to provide quality and regulatory guidance to enhance client satisfaction.
· 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 quality staff to support employee development and satisfaction.
· 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.
· 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.
· Approve method validation protocols, validation reports, test methods, general laboratory protocols and standard operating procedures to assure regulatory compliance.
· Identify areas of “quality weakness” and develop process improvements to insure quality results.
· Develop the quality assurance program to define areas of responsibility, personnel requirements, and operational procedures within the quality program.
· Collaborate with other managerial personnel in formulating, establishing, and maintaining the company quality policies and standard operating procedures.
· Identify gaps in SOPs and ensure robust procedures are developed, implemented and meditated.
· Review and/or contribute to develop applicable SOPs, documents and processes.
· Manage the SOP revision and distribution process according to established timelines, guidelines and procedures, including document control standards and electronic filing.
· Engage in site investigations in order to mitigate any quality-related issues and in identification of new quality improvements.
· Represent the company in regulatory and quality in external regulatory agencies and conferences.
· Review pertinent publications to stay abreast of the regulatory and quality developments within the industry.
· Ensure adherence to highest quality and efficiency standards in laboratory operations.
· 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
· Be actively engaged 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 GMP guidelines.
· 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
· Supervise Document Control/QA Specialist(s)
· Maintain and monitor proficiency testing. Provide specific or generalized summary of proficiency testing trends, issues and failures to the Laboratory Director.
· Develop and implement microbiology procedures
· Involvement in satellite and international laboratories as requested by the VP of Operations
· Provide assistance to Hospital Integration as scheduled by the VP of Operations
· Duties may change as company needs change
· Serve as backup for file maintenance
· Serve as the subject-matter-expert in CLIA/CAP/FDA GMP regulations providing education and assistance to employees and departments to meet and maintain compliance by openly sharing full content and answering questions from team members
· Specific Job Functions:
· Develop standard operating procedures for staff and laboratory personnel
· 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, 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 Manual in accordance with federal, state and local rules and regulations and corporate policies and procedures
· Prepare accident/incident reports and maintaining an accident/incident log in accordance with OSHA Regulations
· Administer the Worker’s Compensation program
· Serve as the subject-matter-expert in Safety regulations by openly providing education and assistance to employees and departments to meet and maintain compliance
· Other duties as necessary to ensure compliance, safety, and quality regulations are known and followed
The ideal candidate would possess :
· 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
· Strong computer, scientific, and organizational skills
· Excellent communication (oral and written) and attention to detail
· Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
· Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
Basic Minimum Qualifications :
· Bachelor's degree in microbiology, biology or other related degree concentration, or equivalent directly-related experience (two years of directly related industry experience is equivalent to one full-time year of college in related major)
· Has extensive experience in clinical microbiology 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.
· Qualify as a Technical Supervisor as defined by CLIA rule § 493.1449
· Knowledge of regulatory agencies to include CLIA, CAP, FDA and respective laws and guidelines.
· Strong understanding of Quality Assurance practices, systems, and software helpful
· Authorization to work in the United States indefinitely without restriction or sponsorship
Position is full-time, Monday-Friday, 8 a.m.-5 p.m., with overtime as needed. Candidates currently living within a commutable distance of Huntsville, AL are encouraged to apply.
As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options.
To learn more about Eurofins, please explore our website www.eurofinsus.com.
Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.