Quality Assurance Coordinator

Job Summary

We are seeking an organized, highly regulatory-minded Quality Assurance (QA) Coordinator to join our analytical testing laboratory. In this role, you will serve as the operational backbone of our Quality Management System (QMS), ensuring the laboratory’s strict adherence to ISO/IEC 17025 standards and cGMP/FDA regulations.

Your work will span the multi-regulatory landscapes of Pharmaceuticals, Medical Cannabis, and Medical Devices. You will manage cross-departmental coordination of laboratory documentation, method validation archives, instrument qualifications, and data integrity audits. The ideal candidate has an eye for detail, a strong background in laboratory compliance, and the ability to ensure all testing data is fully traceable and inspection-ready at all times.

Duties and Responsibilities

• Multi-Industry Regulatory Oversight: Maintain, update, and align the laboratory QMS with current FDA cGMP (21 CFR Parts 210, 211, and 820), ISO/IEC 17025, and state-specific Medical Cannabis laboratory frameworks.
• Laboratory Document Control: Manage the lifecycle of all controlled documents, including standard operating procedures (SOPs), test methods, and analytical protocols.
• Data Integrity Auditing: Conduct routine, thorough administrative audits of laboratory notebooks, electronic raw data, and final analytical reports to ensure strict traceability and compliance with ALCOA+ standards.
• OOS & Deviation Tracking: Log, monitor, and coordinate workflows for Out-of-Specification (OOS) results, laboratory deviations, and Corrective and Preventive Actions (CAPA) from initiation through completion.
• Equipment & Instrument Validation: Coordinate calibration schedules, preventive maintenance logs, and equipment qualifications (IQ/OQ/PQ) for laboratory instrumentation (HPLC, GC, MS, etc.).
• Proficiency Testing Coordination: Manage the laboratory's participation in external Proficiency Testing (PT) programs and interlaboratory comparisons required to maintain ISO accreditation.
• Audit & Inspection Readiness: Assist with scheduling, planning, and hosting internal audits, client audits, and regulatory inspections conducted by the FDA, state cannabis boards, or external ISO accreditation bodies.
• Reagent & Standard Controls: Oversee the archiving and tracking of Certificates of Analysis (CoA) for chemical reference standards, reagents, and media.

Required Skills and Qualifications

• Education: Bachelor’s degree in Chemistry, Biology, Biochemistry, or a related scientific discipline.
• Experience: Minimum of 2–4 years of experience working in an analytical testing laboratory or a regulated quality coordination role.
• Regulatory Knowledge: Hands-on experience with cGMP/FDA regulations (Pharmaceutical or Medical Device) and/or ISO/IEC 17025 compliance frameworks.
• Technical Software Proficiency: Strong working familiarity with a Laboratory Information Management System (LIMS) and electronic document control systems (eQMS).
• Analytical Mindset: Meticulous organizational skills with an uncompromising focus on data accuracy and scientific documentation.
• Communication: Exceptional written and verbal communication skills to effectively collaborate between bench scientists, laboratory management, and external regulatory auditors.

Pay: $68,000.00 - $72,000.00 per year

Benefits:

• Health savings account
• Paid time off
• Parental leave

Work Location: In person