Quality Specialist

Position Summary

The Quality Control Specialist is responsible for reviewing, approving, and maintaining laboratory data and documentation across microbiology and analytical chemistry testing. This role ensures accuracy, integrity, and compliance with cGMP, cGLP, ISO 17025, USP, A2LA, and Eagle Analytical’s Quality Management System. The QC Specialist supports laboratory operations by reviewing test methods, laboratory data, reports, and quality investigations while maintaining regulatory compliance, data integrity, and continuous improvement across testing functions.

• Ensure compliance with company policies, Standard Operating Procedures (SOPs), and the Quality Management System in accordance with Health Canada regulations, ISO 17025, and applicable GxP (cGMP/cGLP) requirements.
• Interpret and apply regulatory, accreditation, and quality standards, including ISO 17025, Health Canada, USP, and A2LA requirements, as applicable to the site.
• Support regulatory inspections, accreditation assessments, and client audits for the satellite laboratory.
• Write, review, and approve SOPs, work instructions, forms, and quality records to ensure regulatory compliance and operational consistency.
• Review and approve analytical chemistry test methods and documentation, including techniques such as HPLC, HPLC-MS/MS, GC-MS, UV-Vis, and other applicable instrumentation.
• Review microbiological test data and documentation related to sterility, endotoxin, bioburden, microbial limits, environmental monitoring, and particulate matter testing, as applicable.
• Review laboratory test reports, worksheets, logbooks, validation protocols, and validation reports for both chemistry and microbiology testing.
• Ensure analytical and microbiological data integrity, accuracy, completeness, and traceability.
• Review and approve quality investigations, including Out-of-Specification (OOS), Nonconformance Reports (NCR), Deviations (DV), Corrective and Preventive Actions (CAPA), change controls, and customer complaints.
• Evaluate root cause analyses and corrective action plans for laboratory and process-related issues.
• Prepare audit finding reports and determine appropriate corrective and preventive actions.
• Support and conduct internal audits of quality systems and laboratory operations.
• Perform routine compliance walk-throughs to ensure ongoing adherence to regulatory and quality requirements.
• Manage the auditing, storage, retention, and control of quality documentation and quarantined materials.
• Prepare and maintain quality-related training materials and support staff training as assigned.
• Communicate quality findings, trends, and risks to laboratory management and quality leadership.
• Support continuous improvement initiatives related to quality systems, documentation, and laboratory compliance.
• Assist in creating and maintaining quality manuals, procedures, and other controlled quality documents.
• Perform additional duties and special projects as assigned to support quality and regulatory objectives at the satellite site.

• Bachelor’s degree in Chemistry, Analytical Chemistry, Microbiology, Biology, or a related scientific discipline required.
• Experience working in a regulated laboratory environment (ISO 17025, cGMP, cGLP) preferred.
• Experience supporting analytical chemistry and/or microbiology testing laboratories preferred.
• Working knowledge of analytical chemistry techniques (HPLC, GC-MS, HPLC-MS/MS, UV-Vis) and/or microbiological testing principles.
• Knowledge of cleanroom practices, environmental monitoring, and microbiology testing is an asset.
• Experience reviewing GMP/GLP documentation, method validations, and quality investigations.
• Strong attention to detail with a demonstrated commitment to data integrity, compliance, and quality.
• Excellent written and verbal communication skills.
• Ability to work independently in a small satellite laboratory environment while collaborating effectively with cross-functional and remote teams.
• Proficiency with Microsoft Office applications and electronic document management systems.
• ASQ certification or other quality-related credentials preferred.

Serving customers since 2004, Eagle offers the highest quality in preparation testing for sterility, bacterial endotoxins, microbial detection, beyond-use dating (BUD) determination and active ingredient potency. State-of-the-art equipment, combined with the experience and knowledge of our team, makes Eagle the best choice for all testing needs. The Eagle team is committed not only to performing the best quality control testing, but also working relentlessly with our customers on solutions if tests receive unexpected results.

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