QA Associate / QA Specialist — Contract Testing Laboratory Job Summary CBL is a growing contract testing laboratory building its Quality Management System from the ground up — and we need someone who wants to build it with us, not just maintain it. We're looking for a QA professional who is resourceful, self-directed, and comfortable operating without a fully paved road . This isn't a role for someone who needs a mature system already in place; it's a role for someone who wants to help create one. You'll work cross-functionally with lab operations, management, clients, suppliers, and external auditors to stand up and maintain compliant systems. You'll take direct ownership of supplier audits, client-facing quality communications, and CBL's
ISO 9001
accreditation process — end to end. The right person treats ambiguity as a problem to solve, not a reason to wait for direction, and brings the same rigor to a blank-page SOP as to a finished one. If you want a seat at the table in a start-up lab, take real ownership of quality from day one, and don't mind rolling up your sleeves to get it right, we want to talk to you. Duties Audits & Accreditation Lead CBL's
ISO 9001
accreditation process, including gap analysis, documentation build-out, readiness assessments, and direct interface with the accrediting body through certification and surveillance audits. Plan, schedule, and conduct supplier audits and qualification assessments ; track supplier corrective actions and maintain the approved supplier/vendor quality file. Assist in preparation for, participation in, and follow-up on internal, client, and regulatory agency audits. Support audit response activities, including corrective action documentation and evidence compilation. Client Interface Serve as a primary quality point of contact for clients — fielding quality-related questions, coordinating client audits, and communicating on nonconformances, CAPAs, and report issues. Oversee and review validation documentation, client protocols, and client study documentation for compliance and completeness. Ensure accurate and timely issuance of client reports. Track and manage customer complaints and identify systemic improvement opportunities from trends. QMS & Documentation Monitor laboratory compliance with reference methods, internal SOPs, and applicable agency-specific requirements. Review, author, revise, and maintain laboratory SOPs, forms, and quality documents. Oversee document control processes to ensure proper versioning, approval, and retention. Maintain controlled historical records, including SOP archives, QC records, and laboratory data. Perform routine review of laboratory logbooks for completeness, accuracy, and compliance. Training & Investigations Maintain employee training records to ensure compliance with QMS and regulatory requirements. Assist with onboarding training coordination for new laboratory personnel; monitor ongoing competency documentation to support audit readiness. Lead or assist in laboratory investigations, including Out-of-Specification (OOS) events and deviations. Develop, document, and monitor Corrective and Preventive Actions (CAPAs); track effectiveness of implemented actions. Education Bachelor's degree in Microbiology, Biology, Chemistry, or a related scientific discipline preferred. Equivalent hands-on QA experience and a proven track record will be considered in lieu of a degree. Experience 2+ years in a regulated laboratory environment (e.g., EPA, FDA, ISO 17025, GMP). Experience conducting or hosting supplier/vendor audits strongly preferred. Experience supporting an
ISO 9001 QMS
build-out or certification/surveillance audit strongly preferred. Direct client-facing quality experience (audit hosting, complaint handling, technical communication) preferred. Technical Competencies Strong understanding of quality systems and regulatory compliance; working knowledge of
ISO 9001
structure and audit expectations. Comfortable planning and executing supplier audits and managing resulting corrective actions. Familiarity with OOS investigations, deviations, and CAPA processes. Knowledge of laboratory reference methods and regulatory frameworks (EPA, FDA, ISO) preferred. Proficiency in document management systems and Microsoft Office. Skills & Attributes Self-starter who takes ownership — builds processes rather than waiting for them to exist; comfortable making judgment calls in a start-up environment with limited precedent. Gritty and resourceful — doesn't get stuck when the "right" tool, template, or answer isn't there yet; finds a compliant way forward. Strong attention to detail and documentation accuracy, even while moving fast. Confident, professional communicator who can hold their own with clients, suppliers, and auditors. Excellent organizational and time-management skills; able to juggle audits, documentation, and investigations concurrently. Able to work independently and collaboratively in a regulated environment. Work Environment Laboratory and office-based environment. Regular interaction with laboratory personnel, management, clients, suppliers, and external auditors.
Job Types:
Full-time, Part-time Pay:
$25.00 - $50.00 per hour Application Question(s): What will matter most to you when deciding whether to accept your next role? Have you supported an
ISO 9001 QMS
build-out, certification audit, or surveillance audit? If yes, what was your involvement? Describe a time you had to build or fix a quality process where no clear procedure existed yet. What did you do?
