EUROFINS VRL INC.
Microbiology CLIA Director
EUROFINS VRL INC., Centennial, Colorado, United States,
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 works with the biggest companies in the world to ensure the products they supply are safe, their ingredients are authentic and labeling is accurate.
Eurofins is the global leader in food, environment, pharmaceutical and cosmetic product testing and in agroscience Contract Research Organisation services. Eurofins 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. The Group also has a rapidly developing presence in highly specialised and molecular clinical diagnostic testing and in-vitro diagnostic products.
In over just 30 years, Eurofins has grown from one laboratory in Nantes, France to 55,000 staff across a decentralised and entrepreneurial network of 900 laboratories in over 50 countries. Eurofins offers a portfolio of over 200,000 analytical methods to evaluate the safety, identity, composition, authenticity, origin, traceability and purity of biological substances and products.
Job Description
GENERAL JOB DESCRIPTION The CLIA Microbiology Director shall: Support Eurofins Donor & Product Testing business philosophy, leadership values and ethics. All employees are expected to meet basic expectations of DPT's quality management system, including, but not limited to good workmanship, adherence to standard operational procedures, training, good documentation practices, accurate recordkeeping so the company may meet its stated quality policy and objectives. Responsible for the development and execution of the laboratory structure and organization at each site. CLIA regulations require a high complexity laboratory to have a Laboratory Director available to oversee the overall operation and administration of the laboratory. Maintain continuous lab operations with integrity and validity for all laboratory activities. Responsible for oversight of the Microbiology laboratory leadership team to ensure timely delivery of quality test results, will interact with customers, provide strong technical leadership, and collaborate effectively across groups within the organization. ROUTINE BUSINESS OPERATIONS
Oversees and directs Eurofins DPT Microbiology and Sterility Management: Focus on strengthening individuals and their capabilities to build a leadership pipeline. Maintain quality accuracy and ensure all quality monitors meet laboratory objectives. Enforce applicable policies and procedures throughout the entire laboratory operation. Develop, implement & enforce laboratory policies, procedures & performance standards affecting a wide range of customer entities (Organ Procurement Organizations, Tissue Banks, etc.). Work directly with the Director of Laboratory Operations to plan, develop, and drive the vision and strategy of this laboratory to meet the company's set objectives. Participate in developing new methodologies & tests and develop strategic planning initiatives. Oversee all laboratory testing and provide scientific expertise to staff for all human-related specimens. Report critical information to Executive Team, as needed. Demonstrate passion and enthusiasm for the company's vision, and motivate, lead, and empower others to achieve company goals. Evaluate automation of current and new testing platforms based on the needs and capacity of the department. Plan and have oversight of the implementation of new instrumentation to increase efficiency of laboratory processes. Recommend new technology/equipment for the laboratory and work within DPT's budget cycle. Establish quantitative financial metrics by which the laboratories efficiency and effectiveness can be evaluated; identify opportunities for improvement (Consumables/personnel as a % of revenue). Ensure timely review and approval of all laboratory procedure and safety manuals, review and approval of all proficiency testing results (before submission to vendor and upon receipt of evaluation report) demonstrated by comments, signature/date. Ensure an annual review of training and competency files and corrective action plans/reports demonstrated by comments, signature/date. Continuous staffing model assessment and oversight of headcount for the Microbiology department. Evaluate department personal headcount structure and prepare justifications for additions. Ensure that prompt corrective action is taken for all lab audit findings or deficiencies noted. Serve as a laboratory departmental liaison during regulatory inspections and/or client audits. Consistent communication with Executive Leadership to ensure they are aware of relevant matters.
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GENERAL JOB DESCRIPTION The CLIA Microbiology Director shall: Support Eurofins Donor & Product Testing business philosophy, leadership values and ethics. All employees are expected to meet basic expectations of DPT's quality management system, including, but not limited to good workmanship, adherence to standard operational procedures, training, good documentation practices, accurate recordkeeping so the company may meet its stated quality policy and objectives. Responsible for the development and execution of the laboratory structure and organization at each site. CLIA regulations require a high complexity laboratory to have a Laboratory Director available to oversee the overall operation and administration of the laboratory. Maintain continuous lab operations with integrity and validity for all laboratory activities. Responsible for oversight of the Microbiology laboratory leadership team to ensure timely delivery of quality test results, will interact with customers, provide strong technical leadership, and collaborate effectively across groups within the organization. ROUTINE BUSINESS OPERATIONS
Oversees and directs Eurofins DPT Microbiology and Sterility Management: Focus on strengthening individuals and their capabilities to build a leadership pipeline. Maintain quality accuracy and ensure all quality monitors meet laboratory objectives. Enforce applicable policies and procedures throughout the entire laboratory operation. Develop, implement & enforce laboratory policies, procedures & performance standards affecting a wide range of customer entities (Organ Procurement Organizations, Tissue Banks, etc.). Work directly with the Director of Laboratory Operations to plan, develop, and drive the vision and strategy of this laboratory to meet the company's set objectives. Participate in developing new methodologies & tests and develop strategic planning initiatives. Oversee all laboratory testing and provide scientific expertise to staff for all human-related specimens. Report critical information to Executive Team, as needed. Demonstrate passion and enthusiasm for the company's vision, and motivate, lead, and empower others to achieve company goals. Evaluate automation of current and new testing platforms based on the needs and capacity of the department. Plan and have oversight of the implementation of new instrumentation to increase efficiency of laboratory processes. Recommend new technology/equipment for the laboratory and work within DPT's budget cycle. Establish quantitative financial metrics by which the laboratories efficiency and effectiveness can be evaluated; identify opportunities for improvement (Consumables/personnel as a % of revenue). Ensure timely review and approval of all laboratory procedure and safety manuals, review and approval of all proficiency testing results (before submission to vendor and upon receipt of evaluation report) demonstrated by comments, signature/date. Ensure an annual review of training and competency files and corrective action plans/reports demonstrated by comments, signature/date. Continuous staffing model assessment and oversight of headcount for the Microbiology department. Evaluate department personal headcount structure and prepare justifications for additions. Ensure that prompt corrective action is taken for all lab audit findings or deficiencies noted. Serve as a laboratory departmental liaison during regulatory inspections and/or client audits. Consistent communication with Executive Leadership to ensure they are aware of relevant matters.
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