About this role
Job Title: Quality Assurance TechnicianJob DescriptionThe 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. 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 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 EnvironmentThe 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. Job Type & LocationThis is a Contract to Hire position based out of Somerville, NJ. Pay and BenefitsThe pay range for this position is $27.00 - $30.00/hr. Individual compensation offered for this position 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.Eligibility requirements apply to some benefits and may depend on your job classification and length of employment. Benefits are subject to change and may be subject to specific elections, plan, or program terms. If eligible, the benefits available for this temporary role may include the following:
• 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) Workplace TypeThis is a fully onsite position in Somerville,NJ. Application DeadlineThis position is anticipated to close on Sep 18, 2026.About Actalent
Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.
The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email [email protected] for other accommodation options.
San Francisco Fair Chance Ordinance: Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the city and county of San Francisco, we will consider for employment qualified applicants with arrest and conviction records.
Massachusetts Lie Detector: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Use of Artificial Intelligence (AI): We may use Artificial Intelligence (AI) to support parts of our hiring process, including sourcing, screening, and evaluating candidates. AI helps assess applications and qualifications, but final decisions are made by our hiring team. By applying, you acknowledge and agree that your application may be reviewed using AI tools.