Senior Technician, Quality

About the role

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. 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. Staff routinely support one another across these areas as workload requires. The role 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, 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 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 prep 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, etc.).
• 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, which will require regularly bending, squatting, stretching, and reaching.
• Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds).
• Specific vision abilities required include close-range distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
• Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer 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 as protection against hazards present in the laboratory environment.

Schedule

This is a fixed shift position: Shift A, 0700 to 1500, 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 to the successful candidate 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.