Job Description

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 shift position: Shift B, 15:00 to 23:00, Monday through Friday, with weekend overtime as applicable based on business needs. This shift does not rotate.

Job 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.

Nothing in this job description restricts management’s right to assign or reassign duties and responsibilities of this job at any time.

Critical 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.

Basic Qualifications:

• 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.

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.) in laboratory.
• 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.
• The person needs to occasionally move between labs, corridors, adjoining rooms, and buildings onsite. Frequently operate on instruments, objects, tools or controls, which will require regularly bending, squatting, stretching and reaching in order to perform in a service function.
• Occasionally move or lift up to 25 pounds (potential for occasional lifting of up to 50 pounds).
• Specific vision abilities required by this position include without limitation, the ability to observe details at close range distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus in order to perform the essential service functions of this position.
• Occasionally operates a computer and other office machinery, such as a calculator, copy machine, and computer printer.
• Employee may be required to handle hazardous waste according to local, state, and federal regulations. Duties may include identifying, handling, generating, accumulating, storing and labeling hazardous waste.
• Potential risk to lab-based hazards including but not limited to 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.