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 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

MINIMUM 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.
• Desired field of degree: Quality Assurance, Regulatory Affairs, Chemistry, Biology or a closely related field.

JOB REQUIREMENTS

• 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

PHYSICAL REQUIRMENTS AND WORKING CONDITIONS

The physical demands and working conditions described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Requirements:

The physical demands described here are representative of those that must be met to successfully perform the essential functions of this job. Reasonable accommodations may also be made to enable individuals with disabilities to perform the essential functions in accordance with applicable law. While performing the duties of this job, incumbent is regularly required to use hands and fingers to feel objects, tools or controls. Position requires standing, sitting, walking and reaching with hands and/or arms, talking clearly and/or hearing and understanding. Position often requires climbing, balancing, stooping or kneeling and occasionally lifting up to 30 pounds. Specific vision abilities required by this position include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Working Conditions:

• While performing the duties of this job, the employee will be in a general office environment.
• The noise level in the work environment is usually moderate.
• This job will require travel to other laboratories in the Southeast Region.

OTHER:

This job description is not an exhaustive list of all duties an employee may be required to perform. Microbac reserves the right to revise the job description at any time.

Employment is at-will. Microbac, promotes a drug-free, alcohol-free workplace. Applicants considered for hire must pass a drug test before beginning work. Refusal to submit to testing will result in disqualification of further employment consideration.

Microbac is an Equal Opportunity Employer - We are committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status. All qualified applicants will receive consideration for employment.