Quality Assurance Specialist

Microbac•Northbrook, IL

12d•$46,500 - $56,000•Onsite

About The Position

The Quality Assurance Specialist, which functions independent from laboratory operations, oversees the development, implementation, and maintenance of quality systems throughout the accredited commercial laboratory in Northbrook, IL and ensures that relevant licenses and accreditations are obtained and maintained. This role will further ensure compliance with all relevant regulatory and company standards while ensuring traceable and defensible data.

Requirements

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.
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

Nice To Haves

Desired field of degree: Quality Assurance, Regulatory Affairs, Chemistry, Biology or a closely related field.
Knowledge and experience in radiochemistry analysis is preferred.

Responsibilities

Ensures that effective and current quality systems are in place and adhered to by all staff, and that the data produced by the laboratory is of the highest quality (i.e.: accurate and defensible).
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 and by the use of Microbac’s Intellect QMS system
Serves as the focal point for QA/QC; has a general knowledge of the analytical methods for which data review is performed, documented training and/or experience in QA/QC procedures and is responsible for the oversight and/or review of quality control data.
Functions independently from laboratory operations for which they have oversight being able to evaluate data objectively and perform assessments without outside influence
Maintains a master list of current versions of local quality documentation; handles the distribution locally maintained documents.
Trains personnel on the management system.
Monitors the corrective action process.
Notifies laboratory management of deficiencies in the quality system.
Oversees the laboratory’s proficiency testing program
Coordinates laboratory accreditation activities
Leads, plans, organizes, and supports the activities and resources related to implementing and maintaining effective quality systems throughout the laboratory including but not limited to document control, CAPA, internal audits, control charts & trend analysis, in-depth data monitoring, approved suppliers and validation of methods, systems & instrumentation
Responsible for continual improvement of the management system through use of control charts and other method performance indicators; e.g., PT samples, internal and external audits.
Writes, reviews and revises SOPs and technical reports
Ensures the laboratory is fully compliant with all relevant regulatory standards
Prepares monthly reports both to local divisional management and to the corporate quality team summarizing quality activities at the laboratory
Serves as the laboratory contact for the Ethics and Data Integrity Program
Hosts and responds to client audits, leads the process to ensure observations are addressed