Quality Assurance Technician

Job Title:

Quality Assurance Technician

Job Description

The Quality Assurance Technician plays a key role in ensuring that sterilization processes and product release activities comply with validated parameters, internal procedures, and regulatory requirements. This position focuses on reviewing cycle records and quality documentation, verifying critical process parameters, supporting audits and inspections, and helping maintain a robust quality management system that safeguards product sterility and consumer safety.

Responsibilities

+ Review sterilization cycle records to verify compliance with validated process parameters as specified in internal procedures.

+ Perform detailed review of load documentation and supporting quality records to confirm accuracy and completeness.

+ Ensure all documentation is complete, accurate, and properly approved prior to product release.

+ Support quality assurance review and approval of sterilized product in accordance with internal procedures and customer requirements.

+ 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 proper system functionality and data integrity.

+ Act as an independent process verifier and/or witness for sterilization activities as required.

+ Support environmental monitoring programs to ensure ongoing control of the manufacturing environment.

+ Ensure strict adherence to current Good Manufacturing Practices (cGMP) and data integrity requirements aligned with ALCOA principles.

+ Promptly triage, address, or escalate any abnormal system performance or alarm conditions to appropriate stakeholders.

+ 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 agencies such as the FDA, notified bodies, and customers, by providing records, participating in inspection activities, and responding to quality-related inquiries.

Essential Skills

+ 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 (CMO) environment.

+ Hands-on experience working within GMP and/or ISO-regulated environments.

+ Strong understanding of quality assurance principles and practices in a regulated industry.

+ Ability to review and interpret sterilization cycle records, load documentation, and supporting quality records.

+ Capability to verify and evaluate critical process parameters, including temperature, humidity, gas concentration, and dose levels.

+ Proficiency in performing software verification activities related to pre-cycle and post-cycle operations.

+ Working knowledge of cGMP and ALCOA data integrity principles and their application in daily operations.

+ Strong attention to detail and accuracy in documentation review and product release activities.

+ Ability to identify, triage, and escalate abnormal system performance, alarms, and potential quality issues promptly.

+ Experience supporting audits and regulatory inspections, including preparation and presentation of quality records.

Additional

Skills & Qualifications

+ Sterility assurance experience, including understanding of sterilization validation and monitoring, is highly desirable.

+

Experience with quality management systems (QMS) in regulated industries.

+ Background in inspection activities and quality oversight of production or sterilization processes.

+ Familiarity with customer-specific quality requirements and documentation standards.

+ Comfort working with cutting-edge technology and automated systems used in sterilization and quality control.

+ Motivation to work in a role with direct consumer impact, ensuring product safety and reliability.

Work Environment

This role operates within a regulated manufacturing and sterilization environment that utilizes cutting-edge technology and automated systems to ensure product sterility and quality. The position…