Laboratory Quality Systems Specialist

BD; Covington (GA); On-site; USD 65,000 - 90,000; Full time

Job summary

BD seeks a Quality Specialist to support laboratory operations by applying quality expertise from test requests to reports and archiving. You will ensure processes meet corporate standards and regulatory requirements while driving continuous improvement.

You will act as the local SME for Quality Systems, lead CAPA activities, manage document control, and promote a culture of quality across the organization.

Qualifications

• Bachelor’s degree in laboratory related science (Chemistry, Microbiology or related field).
• 2 years of experience in a laboratory associated with a regulated industry.
• ASQ Certification: Quality Engineer and/or Quality Auditor is preferred.
• Knowledge of ISO 13485, ISO 17025 and 21 CFR 820 is advantageous.
• Experience with Quality Management Systems and document control.
• Proficiency with MS Office suite (Excel, Word, PowerPoint).

Responsibilities

• Coordinate and maintain a robust, standardized laboratory Quality System aligned with regulatory requirements and Quality Agreements.
• Serve as the local SME for Quality Systems, ensuring compliance and guiding the organization.
• Ensure laboratory processes meet regulatory expectations and business needs.
• Promote a culture of quality and compliance with ISO, QSR, and related regulations.
• Lead implementation of Quality System processes to achieve performance and compliance goals.
• Support document control and record management processes.
• Lead local Quality Objectives and Key Business Drivers for laboratory operations.
• Participate in Quality Leadership meetings and drive progress of quality initiatives.
• Use metrics to monitor effectiveness, identify improvements, and deliver value.
• Drive continuous improvement through lessons learned and preventive actions.
• Support development and training of local quality staff.

Skills

Excel

Word

PowerPoint

Process Improvement

Analytical Skills

Organizational Skills

Communication

Project Leadership

Initiative

Results Oriented

Education

Bachelor’s degree in laboratory related science

ASQ Certified Quality Engineer

ASQ Certified Quality Auditor

Job description

BD seeks a Quality Specialist to support laboratory operations by applying quality expertise from test requests to reports and archiving. You will ensure processes meet corporate standards and regulatory requirements while driving continuous improvement.

You will act as the local SME for Quality Systems, lead CAPA activities, manage document control, and promote a culture of quality across the organization.