Supervisor, Donor Testing Laboratory - 2nd Shift

Job Title

Responsible for the operation of their designated team in accordance with established Standard Operating Procedures (SOPs), applicable sections of the Code of Federal Regulations (CFRs), with emphasis on Good Manufacturing Practices (GMPs), the Clinical Laboratory Improvement Act of 1988 (CLIA), and applicable policies, procedures, and quality initiatives.

Primary Duties & Responsibilities:

As defined by CLIA, this position is responsible for pre-analytic, analytic procedures, maintaining records of tests and for reporting test results in a high complexity laboratory. This position performs only those tests that are authorized by the CLIA laboratory director and performs only those tests that require a degree of skill commensurate with the individual's education, training or experience, and technical abilities. Maintains competency in donor testing functions and performs assigned proficiency testing and follows GMP at all times, with attention to detail. Reviews test results prior to release to meet expected turn around time. Conduct and maintain In-House/Competency Testing with direct observation/evaluation of testing personnel. Assists in training staff in new or revised donor testing assay procedures, equipment use and maintenance procedures and processes. Assists in Maintaining training records of staff. Promotes an engaged workforce through coaching, mentoring, and developing staff. Conducts regular staff meetings and weekly huddles. Develop Performance Evaluation standards. Observe and communicate performance evaluations with staff throughout the year. Provide constructive feedback regularly. Conduct annual performance appraisals in a timely manner and with professionalism. Responsible for hiring new staff with the Laboratory Directory and Manager. Directs day-to-day operation and workflow, promoting efficient processes across all shifts. Manage testing processes to ensure efficient use of reagents and schedule staff to provide adequate coverage during hours of operation. Ensures that preventative/corrective actions are taken when staff, equipment, or test systems are found to deviate from the laboratory's established performance specifications. Maintains inventory and order testing supplies in an efficient and cost-effective manner Address failed runs due to reagent deficiency, staff error, or equipment failures as required by the FDA (Food and Drug Administration). Troubleshoots equipment, schedules preventative maintenance, maintains a spare parts inventory. Utilizes service recovery responses when appropriate. Oversees laboratory inventory management processes for designated platforms. Tasks include reviewing weekly inventory counts against par levels, reviewing pre-qualification runs, performing lot changes, and placing ad hoc orders for supplies. Assist with validation plans and execution as needed. Ensures department provides quality customer services to all customers. Monitors production workflow to ensure department meets TAT requirements for internal and external clients. Provides technical assistance to internal and external customers for laboratory related issues. Coordinates communication during lab crises. Initiates adverse testing event procedure and product recalls for critical testing errors. Accessible to staff to provide on-site, telephone, or electronic consultation to resolve technical problems. Approves PTO requests and performs payroll/timeclock functions. Act as administrator for software systems that drive testing equipment. Acts as back-up for lab or testing related tasks. Oversee the Temperature monitoring system along with other laboratory supervisors. Develop and implement new laboratory procedures and equipment following FDA and AABB (Advancement of Blood & Biotherapies) practices. Revise existing procedures, protocols, and forms to maintain a current and accurate procedure manual.

Secondary Functions:

Promote and contribute to a culture of safety through compliance with all safety SOPs to include wearing proper personal protective equipment (PPE) i.e., safety goggles, gloves, lab coats and proper shoes. Promptly report all safety violation observations and/or safety concerns. Keeps current on blood center issues and reads pertinent materials Assist with CAPA and root cause investigations Conducts effective coaching and/or corrective action meetings for persisting issues or trends, as needed. Participates in ongoing investigational studies of reagents, equipment, new methods, or clinical trials. Assists in training on protocol for clinical trials, maintains regulatory binders, and reports findings to sponsor. Participate in Continuing Education to meet national and state regulatory requirements and maintain records for staff and ensure good standing Conduct educational tours of the laboratory Follow applicable reentry protocols and coordinate supplemental testing Work with Client Services to ensure follow-up testing is scheduled as needed. Act as back-up to other laboratory supervisors as needed.

Qualifications:

Bachelor's degree in Medical Laboratory Science (CLS/MLS/MT) OR Bachelor of Science degree*(see Required Certifications) in chemical or biological science, with minimum requirement of 6 credits of biology and 6 credits of chemistry completed or BA in core sciences (approval is dependent on transcript review). Must meet testing personnel requirements as described in the Clinical Laboratory Improvement Act of 1988 for Highly Complex Laboratory. A minimum of four years of experience in a high-complexity laboratory. National Clinical Laboratory Certification (ASCP (American Society for Clinical Pathology) or equivalent) Knowledge of AABB, FDA and OSHA (Occupational Safety and Health Administration) regulations Working knowledge of Microsoft Suites Comprehend and apply clinical laboratory procedures and theory. Working knowledge of LIS and BECS Working Knowledge of all institutional and personnel policies, confidentiality, and Good Manufacturing Practices (cGMP) Written and oral communication skills and computer input/retrieval Attention to detail and organizational skills Accurate in transcription of numbers Decision making Cultural competency and the ability to communicate effectively in a culturally sensitive manner with both individuals and groups from diverse backgrounds Demonstrate reliability and strong work ethic Resolve problems and customer concerns Maintain composure under pressure Work in a team environment or independently Work irregular hours or overtime as dictated by departmental needs

Schedule:

5 - 8 hr. shifts; Weekdays, 3pm - 11:30pm; Weekends, 2pm - 10:30pm. Rotating weekends and holidays.

The proposed rate of pay for this position is: $87,000 to $97,000 annually.