Senior Technician, Manufacturing Quality - 1st Shift
About The Position
The Senior Technician, Quality supports quality assurance and quality control operations for an insourced laboratory team as part of an End-to-End Laboratory Modernization Program. Depending on assignment, the role focuses on one or more areas: CAPA and non-conformance management, document control, metrology and equipment calibration, records management and digitization, or personnel training and qualification. Team members support one another across these functions as workload requires. The position is based in an ISO 17025-accredited analytical production laboratory at a client site. The Senior Technician independently performs advanced sample preparation and laboratory support activities and provides guidance to Technician staff. The position is onsite Monday through Friday on a non-rotating first shift, 7:00 a.m. to 3:00 p.m. EST. Weekend overtime may apply based on business needs. The work may involve a fast pace and high completion demands, laboratory hazards, protective equipment, hazardous waste handling, and possible medical clearance, respirator training, and fit testing.
Requirements
- High school diploma or equivalent and at least 2 years of relevant laboratory or manufacturing experience, or an associate degree in a science-related field and at least 1 year of relevant experience.
- Demonstrated ability to work independently and mentor others in a regulated laboratory environment.
- Ability to adapt, self-motivate, and manage multiple concurrent preparation tasks with minimal supervision.
- 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.
- Strong organizational skills, technical writing, and documentation review capabilities.
- Effective communication and cross-functional collaboration skills.
- Strong attention to detail and commitment to data integrity.
- Ability to work in a laboratory and controlled environments requiring personal protective equipment.
- Ability to remain stationary more than 25% of the time and occasionally move between labs, corridors, adjoining rooms, and onsite buildings.
- Ability to frequently operate instruments, objects, tools, or controls, including regularly bending, squatting, stretching, and reaching.
- Ability to occasionally move or lift up to 25 pounds, with potential occasional lifting up to 50 pounds.
- Vision abilities including close-range observation, distance vision, color vision, peripheral vision, depth perception, and focus adjustment.
- Ability to operate a computer and office machinery such as a calculator, copy machine, and printer.
- May be required to handle hazardous waste according to local, state, and federal regulations.
- May be required to complete medical clearance, Respiratory Protection Training, and fit testing to wear a respirator.
Nice To Haves
- 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 or records platforms.
- Experience with HPLC.
- Experience coordinating calibration and equipment maintenance programs; familiarity with metrology software and asset management systems.
- Experience developing or coordinating training programs and maintaining competency or qualification records; familiarity with learning management systems.
- Experience in ISO 17025, GLP, GMP, or FDA-regulated environments.
- Familiarity with LIMS and electronic documentation platforms.
Responsibilities
- Maintain controlled documents, including SOPs, work instructions, forms, and quality records; coordinate revisions, approvals, archival, and retention.
- Coordinate calibration and maintenance of laboratory instrumentation; maintain equipment qualification and calibration records and ensure measurement traceability.
- Scan, index, and electronically file laboratory records and quality documents; support retrieval and archival activities.
- Coordinate laboratory training programs and maintain training records; support onboarding, qualification, and competency assessments.
- Track CAPA records, calibration schedules, and training compliance to support timely completion and effectiveness.
- Review documentation for completeness, accuracy, and compliance across CAPA, document control, metrology, records, and training activities.
- Support internal and external audits, inspection readiness, and regulatory compliance activities across quality functions.
- Facilitate cross-functional discussions involving laboratory personnel, quality representatives, and stakeholders.
- Identify opportunities to improve quality systems and streamline processes across quality functions.
- Maintain training and compliance with health, safety, environmental, and operational requirements.
- Train and provide day-to-day guidance to Technician staff on preparation procedures, SOPs, and safe work practices.
- Troubleshoot routine preparation equipment and escalate complex issues appropriately.
- Perform quality checks on completed preparation work before hand-off for analysis.
- Maintain a clean, organized, and well-stocked work area, including routine housekeeping and supply inventory.
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What This Job Offers
Job Type
Full-time
Career Level
Senior
Education Level
Associate degree
