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Laboratory Quality Specialist

Originator: HR
Department: Laboratory

JOB DESCRIPTION

The Laboratory Quality Specialist is principally concerned with the overall quality of Reditus Laboratories and trained clinical laboratory personnel. Quality control is an integral part of laboratory operations. As such, responsibility to maintain laboratory quality control within acceptable parameters resides with all levels of laboratory professional and nonprofessional staff. Although Laboratory management administers the quality control program for that particular lab, Laboratory Quality Specialists ensure that the laboratory is compliant with the rules, regulations and/or quality assurance procedures of the accrediting agency(ies). Laboratory Quality duties fall within one or more of the following categories: training, testing, and evaluation. The training aspect assures that personnel employed in laboratories are adequately trained in the latest techniques by establishing workshops and classes to further their education. In the testing portion, verify proficiency samples are requested, sent, received, tested, and reported by laboratory personnel to test their ability to ascertain the identity, presence and/or quantity of micro-organisms or substances in the sample; results are checked against the returns as a whole, or the findings of an independent, out-of-state laboratory. Evaluation consists of a review of documentation on all facets of a laboratory’s operations and established quality control/assurance procedures to ensure compliance with Federal and accrediting agencies.

DESCRIPTION OF DUTIES

The Laboratory Quality Specialist position includes the following responsibilities:

1. Inspects, evaluates, and reports on laboratory operations concerning laboratory quality assurance policies, practices, and procedures; formulates guidelines for ensuring compliance with quality assurance
2. Develops skills necessary to implement quality control policies and procedures of the
3. Develops/revises standard operating procedures (SOPs) for use in laboratory, maintains up-to-date material and removes outdated material from
4. Conducts internal audits of the Laboratory’s Quality Assurance procedures/policies and prepares comprehensive laboratory inspection reports.
5. Maintains accurate records of corrective actions, preventative actions, personnel training/assessments.
6. Performs other duties as required or assigned which are reasonably within the scope of the duties indicated above.

Requirements

Education and Experience

Preferred Education: Bachelor’s degree in either chemical, biological, medical technology, clinical laboratory sciences, or a related field from an accredited university, supplemented by two years’ professional laboratory or other related experience.

Acceptable Education: Associates degree in a chemical, physical, or biological science or medical lab technology from an accredited college or university supplemented with at least 2 years of increasing supervisory responsibility in a high-complexity laboratory.

Skills and Abilities

• Requires working knowledge of laboratory methods and
• Requires working knowledge of the types of laboratory equipment essential to the operation of clinical laboratories.
• Requires ability     to    attain    effective    working    relationships     with    Laboratory management/staff.
• Requires ability to assist in the preparation of comprehensive laboratory inspection
• Requires ability to maintain accurate laboratory records and prepare activity
• Requires proficiency in Microsoft Office

Other Duties

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice.