Quality Assurance Specialist

Microbac Laboratories, Inc; Northbrook (IL); On-site; USD 60,000 - 80,000; Full time

Job summary

Microbac Laboratories, Inc in Northbrook, IL is looking for a Quality Assurance Specialist responsible for overseeing quality systems in the lab. The role ensures compliance with regulatory standards while implementing effective quality systems.

Candidate should have at least a Bachelor’s degree in a related field with a strong understanding of ISO regulations. This role offers a collaborative environment with a focus on continual improvement and adherence to quality standards.

Qualifications

• Bachelor's degree from an accredited institution or five years of related work experience.
• Knowledge of ISO17025, TNI (NELAC), and environmental laboratory regulations.
• Preferred knowledge in radiochemistry analysis.

Responsibilities

• Establish and maintain management systems in accordance with applicable standards.
• Provide knowledge of analytical methods and QA/QC procedures.
• Monitor and report on the corrective action process.

Skills

Leadership ability

Communication skills

Ability to work in cross-functional teams

Knowledge of ISO17025 and TNI regulations

Knowledge of analytical methods

Education

Bachelor's degree in Quality Assurance, Regulatory Affairs, Chemistry, Biology

Tools

Quality Management System software

Microsoft Office Suite

Job description

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. We serve our clients with the utmost expertise and commitment to exceptional customer experience, refined over 50 years of trusted analytical and measurement experience.

JOB SUMMARY

The Quality Assurance Specialist works independently from laboratory operations, overseeing the development, implementation, and maintenance of quality systems in the accredited commercial laboratory in Northbrook, IL. The role ensures compliance with licenses, accreditations, regulatory, and company standards, and maintains traceable, defensible data.

ESSENTIAL FUNCTIONS

• Ensures effective and current quality systems are in place and adhered to by all staff, guaranteeing the highest quality of laboratory data.
• Serves as the focal point for QA/QC, overseeing or reviewing quality control data such as control charts and calibration records.

KEY RESPONSIBILITIES & ACCOUNTABILITIES

• Establish, implement, and maintain the management system in accordance with applicable standards using Microbac's Intellect QMS system.
• Provide knowledge of analytical methods for data review, documented training and experience in QA/QC procedures.
• Act independently from laboratory operations to evaluate data objectively.
• Maintain a master list of current local quality documentation and handle distribution of locally maintained documents.
• Train personnel on the management system.
• Monitor the corrective action process and notify management of deficiencies.
• Oversee the laboratory's proficiency testing program.
• Coordinate accreditation activities.
• Lead, plan, organize, and support activities related to document control, CAPA, internal audits, control charts, trend analysis, supplier approval, and method validation.
• Drive continual improvement of the management system using control charts and performance indicators (e.g., PT samples, audits).
• Write, review, and revise SOPs and technical reports.
• Ensure full compliance with all relevant regulatory standards.
• Prepare monthly reports for local divisional management and the corporate quality team summarizing quality activities.
• Serve as the laboratory contact for the Ethics and Data Integrity Program.
• Host and respond to client audits, leading the process to address observations.

MINIMUM REQUIREMENTS

• Bachelor's degree from a four-year accredited institution in a related field with two years of related experience, or five years of work experience in lieu of a degree.
• Knowledge of 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.
• Preferred knowledge and experience in radiochemistry analysis.

JOB REQUIREMENTS

• General knowledge of analytical test methods for data review.
• General knowledge of applicable quality systems and accreditation requirements.
• Demonstrated leadership ability.
• Ability to prioritize work and manage time to meet deadlines and rush orders.
• Excellent communication skills.
• Ability to work effectively with cross-functional teams.
• Proficiency with paper and electronic documents, chromatography data systems, and related instrumentation software.
• Experience using a Quality Management System software and Microsoft Office Suite.

PHYSICAL REQUIREMENTS AND WORKING CONDITIONS

Physical demands and working conditions include use of hands and fingers, standing, sitting, walking, reaching, and occasional lifting up to 30 pounds. Vision requirements include close vision, distance vision, color vision, peripheral vision, depth perception, and the ability to adjust focus.

Working Conditions: Employees will work in a general office environment with moderate noise levels.

EMPLOYMENT EQUALITY STATEMENT

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.