Lab Regulatory & Quality Supervisor
: Job Details :


Lab Regulatory & Quality Supervisor

BERKSHIRE HEALTH SYSTEMS

Location: Pittsfield,MA, USA

Date: 2024-11-07T08:27:23Z

Job Description:
DEFINITION/PRIMARY FUNCTIONS # Responsible for ensuring that the laboratory is compliant with all aspects of regulatory agencies# standards and requirements related to regulatory, technical performance, and quality management of the Laboratory. # Assures Laboratory#s compliance with regulatory bodies including CAP, AABB, FDA, DPH, JCAHO, and CLIA and assures tools/policies/procedures are available for staff to use/education.# Responsible for the Laboratory Quality Management programs including performance improvement and technical corrective action activities.# POSITION QUALIFICATIONS (Minimum qualifications are required unless stated otherwise.) Experience: Five (5) years progressively responsible leadership experience in clinical lab science in a hospital lab, reference lab or similar environment. An understanding #of state and federal regulatory compliance requirements for clinical lab operations including CAP# This position also requires an understanding of quality management, quality processes and auditing techniques. Education and Training: N/A License, Certification # Registration: MT (ASCP) certification or equivalent preferred Other Requirements: Must have demonstrated knowledge of laboratory operations, skilled team leader facilitator, excellent verbal, written and presentation skills.## Knowledgeable in preparing and maintaining policies and procedures and a working nowledge of HIS / LIS required.# Knowledge of OSHA, CDC, FDA, CAP, and CLIA regulations as they apply to Laboratory Medicine is required. #* DEFINITION/PRIMARY FUNCTIONS* Responsible for ensuring that the laboratory is compliant with all aspects of regulatory agencies' standards and requirements related to regulatory, technical performance, and quality management of the Laboratory.Assures Laboratory's compliance with regulatory bodies including CAP, AABB, FDA, DPH, JCAHO, and CLIA and assures tools/policies/procedures are available for staff to use/education. Responsible for the Laboratory Quality Management programs including performance improvement and technical corrective action activities.* POSITION QUALIFICATIONS (Minimum qualifications are required unless stated otherwise.)* Experience:* Five (5) years progressively responsible leadership experience in clinical lab science in a hospital lab, reference lab or similar environment. An understanding of state and federal regulatory compliance requirements for clinical lab operations including CAP This position also requires an understanding of quality management, quality processes and auditing techniques.* Education and Training:* N/A* License, Certification & Registration:* MT (ASCP) certification or equivalent preferred* Other Requirements:*
  • Must have demonstrated knowledge of laboratory operations, skilled team leader facilitator, excellent verbal, written and presentation skills.* Knowledgeable in preparing and maintaining policies and procedures and a working nowledge of HIS / LIS required.* Knowledge of OSHA, CDC, FDA, CAP, and CLIA regulations as they apply to Laboratory Medicine is required.
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