Quality Assurance Specialist

Come join our family! If you are interested in truly making a difference in a collaborative and rewarding work setting with a culture of respect, accountability, appreciation, and loyalty, Microbac might be the right place for you!

We offer a positive working environment with engaged and supportive leadership teams along with competitive pay and benefits including medical, dental, vision, life insurance, disability, generous paid time off including vacation, holidays and flextime, a wellness program, referral bonus, tuition reimbursement and more!

ABOUT MICROBAC

Microbac Laboratories, Inc. is a premier commercial laboratory testing firm that partners with clients nationwide, offering laboratory solutions to life science, food and nutrition, and environmental industries and serves our clients with the utmost expertise and respect for their market requirements, constraints, and challenges. We embody a company-wide commitment to exceptional customer experience, which has been refined by over 50 years of trusted, analytical and measurement experience.

As a privately held third-party testing company, Microbac operates with a commitment to our workforce, safety, quality, and compliance. Our diverse work portfolio includes broad accreditation offerings and tested insights across the environmental, food and nutrition and life science markets.

JOB SUMMARY

Under the direction of the Regional Quality Manager, the Quality Assurance Specialist, which functions independent from laboratory operations, oversees the development, implementation, and maintenance of quality systems throughout accredited commercial laboratories in Louisville, KY and the Southeast Region 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.

ESSENTIAL FUNCTIONS

* Is responsible for ensuring 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.

KEY RESPONSIBILITIES &

ACCOUNTABILITIES

* 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…