Senior Quality Assurance Specialist

Canyon Labs exists to raise the standard of services in the Medical Device and Pharmaceutical markets by providing streamlined and expert solutions in technical consulting, sterilization, analytical testing and packaging.

We are committed to ensuring that quality services are delivered by meeting or exceeding customer expectations, continuously improving the effectiveness of the quality system, and ensuring compliance with regulations, standards and directives.

Position Title:
Senior Quality Assurance Specialist

Location: Onsite at Canyon Labs in Bluffdale, Utah

Schedule: Monday – Friday 8:00AM – 5:00PM

Annual Salary Range: $70,000.00 - $80,000.00

The Senior Quality Assurance Specialist plays a key leadership role in ensuring the organization’s GLP, GMP/QMSR, and ISO 17025 operations remain compliant, audit-ready, and aligned with regulatory, customer, and notified body expectations. This role supports the organization by coordinating audits, managing quality events, and ensuring documentation and processes meet both regulatory and internal standards. Senior Quality Assurance Specialist performs detailed documentation reviews, hosts customer, supplier, and regulatory inspections, and leads or supports investigations, deviations, audit responses and corrective actions.

In addition, this role oversees change control activities, contributes to QMS administration, and delivers compliance training across departments. Working closely with Lab Operations, the Senior Quality Assurance Specialist helps identify compliance risks, strengthen quality practices, and maintain a consistent state of audit readiness across the site.

• Coordinate and host customer, supplier, and regulatory audits, including scheduling, document preparation, SME coordination, conducting/hosting the audit, on-site support, drafting and delivering the approved response to findings/observations.
• Maintain audit readiness by ensuring documentation, records, and training requirements are current and compliant with GLP, GMP/QMSR, and ISO 17025 expectations.
• Lead or support quality events, including deviations, CAPAs, laboratory investigations, equipment failures, data integrity issues, audit responses, and customer complaints by gathering information, reviewing documentation, conducting interviews, and assisting in root cause analysis and corrective action development.
• Perform detailed documentation reviews, including study data, reports, logs, forms, and controlled records, to ensure completeness, accuracy, and adherence to internal procedures.
• Help support change control activities for SOPs, forms, equipment, computerized systems and process updates, ensuring appropriate review, approval, and implementation.
• Support QMS administration, including document control, training records, deviation and CAPA tracking, and compliance reporting.
• Conduct internal and supplier audits as part of the audit schedule.
• Deliver compliance-related training for GLP, GMP/QMSR, ISO 17025, GDP, internal procedures, and audit readiness.
• Identify and escalate compliance risks using trends, audit outcomes, and quality event patterns to drive proactive corrective and preventive actions.
• Support Lab Operations in strengthening compliance while driving continuous improvement, standardizing documentation, collaborating across teams, and contributing to a strong QMS that ensures compliance and operational excellence.

• Bachelor’s degree in a scientific or technical discipline (e.g., Chemistry, Biology, Microbiology, Engineering, or related field), or equivalent experience.
• Minimum of 6 years of experience in Quality Assurance, Compliance, or related roles within a GLP, GMP/QMSR, ISO 17025, or similarly regulated environment.

• Strong understanding of GLP (21 CFR Part 58), GMP/QMSR (21 CFR Parts 210/211/820), and ISO/IEC 17025 principles.
• Experience coordinating and hosting customer, supplier, and/or regulatory audits.
• Demonstrated experience supporting or writing investigations,…