Sr Quality Technician

The Sr. Quality Technician – Metrology provides Quality Assurance support across multiple departments, ensuring compliance with internal procedures and regulatory standards. This role is responsible for supporting calibration, preventative maintenance, inspection, and quality system documentation activities.

This position builds upon foundational Quality Technician responsibilities and requires a higher level of independence, technical expertise, and collaboration with cross-functional teams. The role plays a key part in maintaining quality systems and ensuring the timely delivery of compliant product

Key Responsibilities

• Review and assess processes and products to ensure compliance with quality standards and regulatory requirements
• Support batch record review and assist with timely product release
• Participate in quality investigations, including root cause analysis and CAPA activities
• Maintain accurate documentation to support audits and inspections
• Follow all company policies and Quality System requirements

• Perform Level 1, 2, and 3 calibrations (e.g., pipettes, pressure, temperature, scales, centrifuges, freeze dryers, torque, encoders)
• Enter and maintain calibration and preventative maintenance data in CAL/PM systems
• Review and approve calibration and maintenance records
• Perform second-person verification of calibrations
• Schedule vendor calibrations and escort vendors as needed
• Identify and respond to out-of-tolerance and out-of-calibration events
• Monitor temperature alarms and determine corrective actions
• Initiate NCRs for nonconforming conditions

• Conduct contamination swabbing and in-process quality checks
• Support equipment onboarding and validation activities
• Review quality documentation for accuracy and completeness
• Assist with training and cross-functional quality initiatives
• Support other QA subunits as needed

• High School Diploma or GED (or equivalent)
• Minimum 2 years of experience in a regulated environment, including:
  • 1+ year in Quality Assurance, Quality Control, manufacturing, laboratory, or life sciences environment
• Knowledge of GMP, ISO 9001, ISO 13485, and/or 21 CFR Part 820
• Strong communication and organizational skills
• Proficiency with Microsoft Office (Outlook, Teams, Word, Excel)

• Ability to wear PPE for extended periods
• Ability to stand, walk, and sit for moderate durations
• Ability to lift up to 50 lbs (regularly at least 25 lbs)
• Ability to navigate manufacturing environments (stairs, ladders, etc.)
• Minimal travel (primarily for training, if required)

• Associate degree or higher in life sciences, engineering, or related field
• Experience with calibration systems or metrology equipment

• Strong attention to detail and accuracy
• Ability to manage multiple priorities in a fast-paced environment
• Effective communication and collaboration skills
• High level of integrity and accountability
• Ability to work independently with minimal supervision