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?
Experience:
- Quality assurance: 2 years (Required)
Language:
Ability to Commute:
- Rockville, MD 20850 (Required)
Work Location: In person
