Under the direction of the Regional Quality Manager, the Quality Assurance Specialist oversees the development, implementation, and maintenance of quality systems throughout accredited commercial laboratories in Louisville, KY and the Southeast Region
Ensures that relevant licenses and accreditations are obtained and maintained.
Ensures compliance with all relevant regulatory and company standards while ensuring traceable and defensible data.
Is responsible for ensuring that effective and current quality systems are in place and adhered to by all staff.
Serves as the focal point for QA/QC and is responsible for the oversight and/or review of quality control data such as data, control charts, calibration records, and other QA/QC data.
Ensures that the management system is established, implemented, and maintained in accordance with the applicable standards in their laboratory.
Functions independently from laboratory operations and is able to evaluate data objectively.
Monitors the corrective action process.
Notifies laboratory management of deficiencies in the quality system.
Oversees the laboratory’s proficiency testing program.
Prepares monthly reports both to local divisional management and to the corporate quality team summarizing quality activities at the laboratory.

Bachelor’s degree from a four-year accredited institution in a related field and two years of related experience or 5 years work experience in lieu of a degree
Knowledge of applicable management system standards ISO17025, TNI (NELAC) and preferably environmental laboratory state regulations.
Knowledge of accreditation and/or certification processes.
Desired field of degree: Quality Assurance, Regulatory Affairs, Chemistry, Biology or a closely related field.
General knowledge of analytical test methods for which data review is performed.
General knowledge of applicable quality systems and accreditation, licensing and/or certification requirements.
Demonstrated leadership ability.
Ability to effectively prioritize work and manage time to meet deadlines and rush orders
Excellent communication skills.
Ability to work effectively with cross-functional teams.
Use of both paper and electronic documents and files, chromatography data systems, or other instrumentation software.
Ability to work in Quality Management System software system and Microsoft Office Suite.

Quality Assurance Specialist

Key skills