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. Focuses on 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. Operates within an ISO 17025 accredited analytical production laboratory at a client site.

Responsibilities

• Maintain controlled documents, including SOPs, work instructions, forms, and quality records; coordinate revisions, approvals, archival, and retention requirements.
• Coordinate calibration and maintenance activities for laboratory instrumentation; maintain equipment qualification and calibration records; 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; 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 escalate 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.

Requirements

• 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 tasks with minimal supervision.

Skills

• 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.

Preferred Qualifications

• 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; familiarity with learning management systems.
• Experience within ISO 17025, GLP, GMP, or FDA-regulated environments.
• Familiarity with LIMS and electronic documentation platforms.

Working Environment

• Must be able to work in a laboratory, controlled environments requiring personal protective equipment (e.g., lab coat, safety glasses).
• Job pace may be fast and job completion demands may be high.
• Must be able to remain in a stationary position more than 25% of the time.
• Occasionally move between labs, corridors, adjoining rooms, and buildings onsite.
• Frequently operate instruments, objects, tools, or controls; regularly bend, squat, stretch, and reach.
• Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds).
• Specific vision abilities required: close-range distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• Occasionally operates a computer and other office machinery (calculator, copy machine, printer).
• May be required to handle hazardous waste according to local, state, and federal regulations.
• Potential risk to lab-based hazards including extreme temperature, biological materials, and hazardous chemicals.
• May be required to complete Medical Clearance, Respiratory Protection Training, and Fit Testing to wear a respirator.

Schedule

Fixed overnight shift: 23:00 to 07:00, Monday through Friday, with weekend overtime as applicable based on business needs. This shift does not rotate.

Pay

The annual compensation range for this full-time position is $50,000 to $60,000. The final base pay offered will be determined by factors including internal equity, work location, as well as individual qualifications, such as job-related skills, experience, and relevant education or training.