Quality Assurance Technician

About the role

The Quality Assurance Technician ensures that sterilization processes, documentation, and product release activities consistently meet validated process parameters, internal procedures, and customer requirements. This role focuses on reviewing sterilization cycle records, verifying critical process parameters, and supporting quality system activities to maintain compliance with cGMP, ISO standards, and data integrity principles. The position offers exposure to cutting-edge technology and the opportunity to make a direct impact on consumers by helping ensure product sterility and safety.

Responsibilities

• Review sterilization cycle records to verify compliance with validated process parameters as defined in internal procedures.
• Perform detailed review of load documentation and supporting quality records to confirm accuracy, traceability, and completeness.
• Ensure all documentation is complete and accurate prior to product release, in alignment with internal quality system requirements.
• Support quality assurance review and approval of sterilized product in accordance with internal procedures and customer specifications.
• Verify that critical process parameters, such as temperature, humidity, gas concentration, and dose levels, remain within validated ranges.
• Perform pre-cycle and post-cycle software verification activities to confirm correct setup, execution, and data capture of sterilization cycles.
• Act as an independent process verifier and/or witness for critical process steps, as required by procedures.
• Support environmental monitoring programs by performing or reviewing monitoring activities and associated records, as needed.
• Ensure adherence to current Good Manufacturing Practices (cGMP) and data integrity requirements, including ALCOA principles.
• Promptly triage, address, or escalate any abnormal system performance or alarm conditions in accordance with escalation procedures.
• Escalate quality issues that may impact product sterility assurance or regulatory compliance in a timely and documented manner.
• Support internal and external audits and regulatory inspections, including those conducted by regulatory authorities, notified bodies, and customers, by providing records, explanations, and documentation as requested.

Qualifications

• Associate degree or higher in a scientific or engineering discipline.
• 2–5+ years of quality experience in a sterilization, pharmaceutical, biotechnology, medical device, or contract manufacturing organization environment.
• Hands-on experience working in GMP or ISO-regulated environments.
• Demonstrated experience in quality assurance, quality inspection, or related quality functions.
• Ability to review and interpret sterilization cycle records, load documentation, and supporting quality records.
• Proficiency in verifying critical process parameters such as temperature, humidity, gas concentration, and dose levels.
• Experience applying current Good Manufacturing Practices (cGMP) and data integrity principles, including ALCOA.
• Ability to support and participate in audits and regulatory inspections by providing accurate records and clear explanations.
• Strong attention to detail and accuracy in documentation review and record-keeping.
• Ability to identify, triage, and escalate abnormal system performance, alarm conditions, and quality issues.
• Strong written and verbal communication skills for documenting findings and collaborating with cross-functional teams.

Additional Skills & Qualifications

• Sterility assurance experience, including familiarity with sterility assurance concepts and practices.
• Experience with quality management systems (QMS) related to sterilization or regulated manufacturing environments.
• Background in sterility-focused quality systems, including documentation and process verification.
• Exposure to inspection activities within a regulated quality environment.
• Familiarity with ISO-based quality systems in pharmaceutical, biotech, medical device, or contract manufacturing settings.
• Interest in working with cutting-edge technology used in sterilization and quality assurance.
• Motivation to contribute to products that have a direct impact on consumers and patient safety.

Work Environment

The role operates within a regulated manufacturing and quality environment that supports sterilization processes and quality management systems. The position follows defined shifts, typically including a 7:00 a.m. to 3:30 p.m. shift and a 2:30 p.m. to 10:00 p.m. shift, which may involve rotating or assigned schedules based on operational needs. Work involves frequent interaction with sterilization equipment, environmental monitoring systems, and quality documentation tools, including software used for pre-cycle and post-cycle verification. The environment emphasizes adherence to cGMP, ISO standards, and robust data integrity practices. Team members work closely with operations, quality, and technical staff in a structured setting that supports audits and regulatory inspections. Appropriate attire is expected for a controlled, regulated facility, including compliance with any gowning, protective clothing, or cleanliness requirements associated with sterile or controlled areas.

Pay

$27.00 - $30.00/hr. Individual compensation offered within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors.

Schedule

This is a Contract to Hire position based out of Somerville, NJ. Fully onsite. Typical shifts include 7:00 a.m. to 3:30 p.m. and 2:30 p.m. to 10:00 p.m., which may involve rotating or assigned schedules based on operational needs.

Benefits

If eligible, benefits for this temporary role may include: Medical, dental & vision; Critical Illness, Accident, and Hospital; 401(k) Retirement Plan – Pre-tax and Roth post-tax contributions available; Life Insurance (Voluntary Life & AD&D for the employee and dependents); Short and long-term disability; Health Spending Account (HSA); Transportation benefits; Employee Assistance Program; Time Off/Leave (PTO, Vacation or Sick Leave).