Sr. Technician, Quality
Listed on 2026-09-12
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Quality Assurance - QA/QC
Quality Control - QC Analysts/Managers, Production QC/QA
The Sr. Technician, Quality supports quality assurance and quality control operations for the insourced laboratory team as part of an End-to-End (E2E) Laboratory Modernization Program. Depending on assignment, this role concentrates in one or more of the following areas: CAPA and non-conformance management, document control, metrology and equipment calibration, records management and digitization, or personnel training and qualification. Because these functions operate as a single Quality team, staff routinely support one another across these areas as workload requires.
This role operates within an ISO 17025 accredited analytical production laboratory at a client site. The Senior Technician independently performs advanced sample preparation and laboratory support activities for these functions and provides guidance to Technician staff.
This is a fixed overnight shift position:
Shift C, 23:00 to 07:00, Monday through Friday, with weekend overtime as applicable based on business needs. This shift does not rotate.
- Maintain controlled documents, including SOPs, work instructions, forms, and quality records, and coordinate revisions, approvals, archival, and retention requirements.
- Coordinate calibration and maintenance activities for laboratory instrumentation, maintain equipment qualification and calibration records, and ensure measurement traceability.
- Perform scanning, indexing, and electronic filing of laboratory records and quality documents; support records retrieval and archival activities.
- Coordinate laboratory training programs, maintain training records, and support onboarding, qualification, and competency assessments for laboratory personnel.
- Track CAPA records, calibration schedules, and training compliance to ensure timely completion and effectiveness.
- Review documentation for completeness, accuracy, and compliance with quality requirements across CAPA, document control, metrology, records, and training activities.
- Support internal and external audits, inspection readiness, and regulatory compliance activities across all quality functions.
- Facilitate cross-functional discussions involving laboratory personnel, quality representatives, and stakeholders.
- Identify opportunities to improve quality systems and streamline processes across CAPA, document control, metrology, records management, and training.
- Maintain training and compliance in health, safety, environmental, and operational requirements.
- Train and provide day-to-day guidance to Technician staff on prep procedures, SOPs, and safe work practices.
- Perform basic troubleshooting of routine preparation equipment and elevate complex issues appropriately.
- Perform quality checks on completed prep work prior to hand-off for analysis.
- Maintain a clean, organized, and well-stocked work area, including routine housekeeping and supply inventory.
- Strong understanding of CAPA principles, deviation management, and root cause analysis techniques.
- Knowledge of document control, records management, and metrology/calibration program requirements.
- Ability to coordinate training programs and competency assessments.
- Knowledge of ISO 17025 quality systems and regulatory requirements.
- Excellent organizational skills, technical writing, and documentation review capabilities.
- Effective communication and cross-functional collaboration skills.
- Strong attention to detail and commitment to data integrity principles.
- High school diploma or equivalent with 2+ years of relevant laboratory or manufacturing experience.
- OR Associate degree in a science-related field with 1+ years of relevant experience.
- Demonstrated ability to work independently and mentor others in a regulated laboratory environment.
- Adaptable, self-motivated, and capable of managing multiple concurrent prep tasks with minimal supervision.
- Experience managing CAPA systems and non-conformance investigations, including root cause analysis and continuous improvement methodologies.
- Experience supporting document control systems, records management, and electronic document/records platforms.
- Experience coordinating calibration and equipment maintenance programs; familiarity with metrology software and asset management systems.
- Experience developing or coordinating training programs and maintaining competency/qualification records;…
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