Job Description

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 labelling 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

PURPOSE

In order to comply with all regulatory requirements, Boston Heart Diagnostics will have one or more qualified individual(s) who, under the general direction of the Laboratory Director, manage/supervise technical personnel and the reporting of findings; perform tests requiring special scientific skills, and, in the absence of the director, be responsible for the proper performance of all laboratory procedures. The Laboratory Supervisor must ensure the quality of all laboratory processes and compliance with all regulatory requirements. The Lab Supervisor oversees all phases of laboratory testing and may also be required to perform Medical Technologist duties as needed.

ESSENTIAL JOB FUNCTIONS AND RESPONSIBILITIES

• Monitors and ensures compliance with all regulatory and accreditation requirements;

• Oversees the day-to-day operation of the laboratory to ensure smooth flow of samples and testing. Supports the company towards meeting company-wide goals;

• Has an active role with personnel; hires, coaches, reviews, manages, and terminates assignments as needed;

• Oversees all lab operations and functions for the assigned area, including proficiency testing, personnel, lab safety compliance, maintains lab operational workflow;

• Develops, implements, and monitors operational systems in accordance with state and federal guidelines (i.e. Quality Systems, Personnel training & competency, Proficiency Testing, Documentation Systems, Occurrence Management);

• Ensures compliance and inspection readiness at all times in accordance with federal regulations that apply to the testing facility;

• Monitors equipment maintenance and calibration of laboratory instrumentation to ensure equipment functionality. Proactively schedules maintenance visits;

• In the event of non-conformances, ensures that results of test examinations are not reported until all corrective actions have been taken and the test system is properly functioning;

• Assures that all remedial actions are taken whenever test systems deviate from the laboratory’s established performance specifications;

• An individual functioning as a manager/supervisor may delegate, in writing, responsibilities such as quality control review and quality assurance activities to other competent and trained supervisor-qualified staff, provided supervisory review of these activities is documented (i.e. via periodic communications, summary reports, etc.) and non-conforming events are brought to the attention of the area manager/supervisor;

• Analyzes needs for new or updated equipment and assesses efficacy of proposed instrument acquisitions;

• Works with the Lab Director and Director of Operations on analyzing requests for new tests;

• Follow the laboratory's procedures for specimen handling and processing, and maintaining records of test examinations;

• Maintain records that demonstrate that proficiency testing samples are tested in the same manner as patient specimens;

• Adhere to the laboratory's quality control policies, document all quality control activities, instrument and procedural calibrations and maintenance performed;

• Follow the laboratory's established policies and procedures whenever test systems are not within the laboratory's established acceptable levels of performance;

• Demonstrate strong teamwork skills by effectively communicating, knowledge sharing and adequately prioritizing tasks to efficiently complete daily activities;

• Maintain adequate inventory of supplies, reagents and material – escalate immediately when faced with shortage of supplies;

• Plays an active role in process improvement projects with potential for significant improvement in quality, efficiency, and/or reduction in cost of testing.

• Possess critical thinking skills and is able to actively troubleshoot when even the slightest deviations are observed.

Qualifications

MINIMUM

QUALIFICATIONS

Basic Educational

Qualifications

(1) Successful completion in an accredited college or university of a full course of study which meets all academic requirements for a bachelor's degree in medical laboratory science; the degree program shall have included a one year structured clinical laboratory experience in either (a) the general areas of a clinical laboratory, or (b) in a specialty area; or

(2) Successful completion of three academic years of study (a minimum of 90 semester hours or equivalent) in an accredited college or university which met the specific requirements for entrance into a school of medical laboratory science and the successful completion of a course of training of at least 12 months in a school of medical technology approved by the Council on Medical Education of the American Medical Association; or

(3) Successful completion in an accredited college or university of a course of study which meets all academic requirements for a bachelor’s degree in one of the chemical, physical or biological sciences and, in addition, at least one year of full-time laboratory experience and/or training subsequent to graduation covering the specialty(ies) or subspecialty(ies) in which the individual performs tests; or

(4) Successful completion of three years (90 semester hours or equivalent) in an accredited college or university with a distribution of courses as shown below, and, in addition, successful experience and/or training covering several fields of medical laboratory work of such length (not less than one year), and of such quality that this experience or training, when combined with the education, will have provided the individual with education and training in medical technology equivalent to that described in paragraph (1) or (2) above. Distribution of course work: (Where semester hours are stated, it is understood that the equivalent in quarter hours is equally acceptable. The specified courses must have included lecture and laboratory work. Survey courses are not acceptable.)

(i) for those whose training was completed prior to September 15, 1963: At least 24 semester hours in chemistry and biology courses of which not less than nine semester hours must have been in chemistry and must have included at least 6 semester hours in inorganic chemistry, and not less than 12 semester hours must have been in biology courses pertinent to medical sciences;

(ii) for those whose training was completed after September 15, 1963: 16 semester hours in chemistry courses, which included at least 6 semester hours in inorganic chemistry and are acceptable toward a major in chemistry; 16 semester hours in biology courses which are pertinent to the medical sciences and are acceptable toward a major in the biological sciences; and 3 semester hours of mathematics.

Basic Minimum

Qualifications

1. 6 years’ experience in specialty or subspecialty area.
2. Considerable knowledge of the methods, materials, and techniques used in laboratory work
3. Considerable knowledge of the use of laboratory apparatus and equipment
4. Ability to organize, communicate, teach, and work with others in an effective manner.

• Willingness to work with potentially infectious human blood and bodily fluids.

• Ability to work with automated and manual platforms.

• Strong computer, scientific and organizational skills, strong sense of personal accountability and responsibility.

• Demonstrates a high level of integrity and honesty in performing tests, documenting test results and maintaining patient, client, employee and laboratory business confidentiality.

• Analytical judgement, problem solving skills, accuracy and strong detail-oriented approach to performing tasks.

• Meets basic expectations of Eurofins’s quality management system, including, but not limited to good workmanship, adherence to standard operational procedures, training, good documentation practices, accurate recordkeeping.

PREFERRED

QUALIFICATIONS

• Working knowledge of Document Control systems

• Advanced knowledge of Excel and Microsoft Word

• Thorough understanding of CLIA, CAP, NYS regulatory requirements

• Previous supervisory experience in the specific departmental specialty

• Excellent written and verbal communication skills

• Strong understanding of Good Documentation/Laboratory Practices

• Good hand-eye coordination

• Meets CLIA, MA, and NYS Technical Supervisor qualification

PHYSICAL DEMANDS

• Physical dexterity sufficient to use hands, arms, and shoulders repetitively to operate manual and automated single and multichannel pipettes.
• Ability to speak and hear well enough to communicate clearly and understandably with sufficient volume to ensure an accurate exchange of information in normal conversational distance, over the telephone, and in a group setting.
• Ability to continuously operate a computer, analytical instrument, or liquid handling platform for extended periods of time.
• Mental acuity sufficient to collect and interpret data, evaluate, reason, define problems, establish facts, draw valid conclusions, make valid judgements and decisions.

Additional Information

Schedule:

• Monday-Friday 8:00am-5:00pm

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 USA Clinical Diagnostics is a Disabled and Veteran Equal Employment Opportunity employer.

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