Job Description Summary

Under limited direction, this position is responsible for coordinating the testing of biological specimens and reviewing test results and quality assessment data. This position is also responsible for providing skilled technical oversight in the laboratory. Serves as a resource to departments outside area of primary responsibility. Works with other team members to ensure timely and quality test results.

Job Description

PRIMARY DUTIES AND RESPONSIBILITIES

• Hires, supervises, trains, and evaluates performance of assigned personnel. Identifies and effectively resolves personnel issues.
• Leads and develops staff and supervises workflow.
• Supervises survey and proficiency testing and ensures timely completion.
• Conducts required competency assessments and completes documentation. Takes appropriate corrective action as necessary. Provides routine and non-routine training to staff, as required, and ensures all training and/or re-training is documented.
• Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
• Supervises and performs routine testing of biological samples. Ensures completion of reagent preparation, pre-qualification, and quality assurance. Ensures accurate records and documentation maintenance.  Ensures donor, patient, and employee confidentiality. Accountability for timely release of test results.
• Maintains acceptable attendance and punctuality per the absence policy.
• Liaises with vendors and clients and provides direct customer service. Communicates with customers, vendors, and couriers to ensure quality service. Assures quality customer service to all customers.
• Makes recommendations to revise policies and procedures, as appropriate.
• Ensures and performs preventive maintenance, quality assurance and calibrations on equipment.  Identifies and repairs more complex equipment malfunctions, performs trouble shooting and notifies appropriate personnel if additional service is needed.
• Ensures and is accountable for maintaining an adequate level of supplies and reagents.
• Ensures the cleanliness of equipment and work areas. Ensures and is accountable for safety guidelines adherence.
• Investigates deviations in testing, quality control and preventative maintenance. Is responsible for corrective action and escalates to appropriate management as necessary.
• Supervises and performs evaluations of reagents, equipment, and new testing methods.
• Participates on process improvement teams.
• Performs all other duties, at the discretion of management, as assigned.

REQUIRED QUALIFICATIONS

• Education & Experience Option 1:
• Bachelor's Degree in Medical Technology,
• At least 4 years of subsequent laboratory experience, to include 2 years of experience in a progressively responsible role, such as lead and/or supervisor, and at least 1 year of workflow coordination experience;

OR

• Education & Experience Option 2:
• Bachelor's Degree or higher from an accredited institution in chemical, physical or biological sciences where education and training meet CFR 493.1489,
• Six months of supervised relevant training/experience and at least 4 years of subsequent laboratory experience, to include 2 years of experience in a progressively responsible role, such as lead and/or supervisor, and at least 1 year of workflow coordination experience;

OR

• Education & Experience Option 3:
• Master’s Degree from an accredited institution in chemical, physical or biological sciences where education and training meet CFR 493.1489,
• Six months of supervised relevant training/experience and at least 2 years of subsequent laboratory experience, to include 2 years of experience in a progressively responsible role, such as lead and/or supervisor, and at least 1 year of workflow coordination experience.
• MT, MLS ASCP (or equivalent)  Certification required.
• CLIA requirements for High Complexity Testing required.
• Appropriate state licensure and/or certificate, where applicable, required.
• Must possess High Complexity Testing competencies required by Standard Operating Procedures (SOPs), CLIA, and other applicable regulatory and accrediting bodies required.
• Must possess demonstrated advanced clinical laboratory knowledge and competency so as to provide testing quality control, as well as proficient training and guidance to newer staff.
• Must possess demonstrated proficiency of complex equipment and reagent maintenance, for troubleshooting, and problem resolution. Advanced proficiency must be demonstrated with all equipment at the assigned location.
• Must possess demonstrated understanding of, and experience with, proficiency survey sample testing.
• Must possess demonstrated equipment calibration and qualification proficiency for all equipment at the assigned location.
• Must possess advanced clinical laboratory competency expertise that meets regulatory and SOP requirements, so as to conduct staff competency assessments and training.

PREFERRED QUALIFICATIONS

• Trainer Certification preferred.

SKILLS AND ABILITIES

• Must possess the skills and abilities to successfully perform all assigned duties and responsibilities.
• Must be able to maintain confidentiality.
• Must have analytical, statistical, personal organization, and problem-solving skills.
• Must have proficient computer skills.
• Ability to think strategically and independently.
• Effective oral and written communication skills.       
• Ability to establish priorities and follow through on projects, paying close attention to detail with minimal supervision.
• Able to organize, prioritize, and execute a variable workload and multiple priorities.

PHYSICAL & TRAVEL REQUIREMENTS

• Lab work environment: Exposure to biological fluids with potential exposure to infectious organisms. Exposure to extreme cold ( ≤ -20⁰C), miscellaneous production chemicals, moving machinery and production equipment. Exposure to high levels of noise on the production floor. Personal protective equipment is required such as protective eyewear, garments and gloves. Specific vision abilities required by this job include close vision, distance, color, peripheral vision, depth perception and the ability to adjust focus.
• Travel: < 5%
• 5+ hours per shift: Sitting, standing, handling, finger dexterity, pinching
• 3- 5 hours per shift: Lifting to 40 pounds
• Up to 3 hours per shift: Walking, climbing, bending, squatting, reaching above shoulders, reaching waist to shoulder, reaching knee to waist, reaching floor to knee, grasping items, carrying/move items up to 40 pounds

The above statements are intended to describe the general nature and level of work performed by people assigned to this job.  They are not intended to be an exhaustive list of responsibilities, duties, and skills required of personnel so classified. The job description reflects the general details considered necessary to describe the principal functions of the job identified and shall not necessarily be construed as a detailed description of all the work requirements that may be inherent in the job. Creative Testing Solutions is an Equal Opportunity Employer.

Creative Testing Solutions is an equal opportunity employer.

EEO/Minorities/Females/Disabled/Veterans

Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail to [email protected] to let us know the nature of your request. A representative will respond to accommodation requests within five business days.  Please note that this email is for medical/disability accommodations only and any other inquiries will not receive a response.

Please see the below information about applicant rights and our commitment to compliance:

Know Your Rights: Workplace Discrimination is Illegal

Pay Transparency Nondiscrimination Provision

E-Verify Participation

Right to Work

All candidates who receive a conditional written offer of employment will be required to undergo a pre-employment drug test in accordance with the Company's established guidelines.