QA Technician

Job Summary

We are seeking a skilled professional to join our team in ensuring the quality and compliance of our sterilization processes. This role involves reviewing sterilization cycle records, verifying critical process parameters, and supporting audits and inspections. The ideal candidate will have strong attention to detail, excellent communication skills, and the ability to manage multiple priorities in a fast-paced environment.

Primary Responsibilities

• Review sterilization cycle records to verify compliance with validated process parameters as specified in internal procedures.
• Perform detailed reviews of load documentation and supporting quality records.
• Ensure completeness and accuracy of documentation prior to product release.
• Support QA review and approval of sterilized products in accordance with internal procedures and customer requirements.
• Verify that critical process parameters (e.g., temperature, humidity, gas concentration, dose levels) are within validated ranges.
• Conduct pre-cycle and post-cycle software verification activities.
• Act as an independent process verifier and/or witness as required.
• Support environmental monitoring programs as needed.
• Ensure adherence to Good Manufacturing Practices (cGMP) and data integrity (ALCOA) requirements.
• Promptly address, triage, or escalate any abnormal system performance or alarm conditions.
• Escalate quality issues that may impact product sterility assurance or regulatory compliance promptly.
• Support audits and regulatory inspections (e.g., FDA, notified bodies, customer) as required.
• Achieve established productivity and quality performance goals while supporting operational excellence.
• Adhere to all safety rules, quality standards, company policies, and procedures.
• Perform all assigned tasks in a safe, efficient, and productive manner.
• Execute additional responsibilities as assigned to support departmental and organizational objectives.

Knowledge, Skills & Qualifications

• Associate's degree or higher in engineering, science, or a related technical discipline, or equivalent experience.
• 2–5 years of quality experience in a GMP-regulated industry, preferably contract sterilization.
• Understanding of sterilization processes and associated standards.
• Familiarity with sterility assurance concepts.
• Strong attention to detail with the ability to review complex technical documentation.
• High level of professionalism with excellent interpersonal and customer service skills.
• Exceptional time management abilities with proven success managing multiple priorities simultaneously.
• Outstanding verbal and written communication skills.
• Strong quality and compliance mindset.
• Demonstrated ability to take ownership and drive tasks to completion.
• Demonstrated ability to work independently, collaborate effectively in a team, and drive projects to completion.
• Ability to work in a fast-paced environment with the flexibility to adjust to and adapt to shifting priorities.
• Strong analytical and problem-solving skills with sound decision-making capabilities.
• Dependable, punctual, and committed to maintaining a positive attitude and strong work ethic.
• Must be authorized to work in the United States.

Essential Functions/Physical Requirements

• Must be able to lift and move up to 40 lbs.
• Frequently required to stand, walk, sit, use hands to handle and feel, use arms to reach, climb, balance, stoop, kneel, crouch, crawl, talk, and hear.
• Full range of motion for wrist, hand, and finger dexterity.
• Distance vision/peripheral vision, depth perception, and ability to adjust focus.
• Must be able to operate a computer and other office machinery such as a copy machine and printer.

Shift, Hours, and Pay Rates

• 1st shift: 7am – 3:30pm
• 2nd shift: 2:30pm – 11pm
• Compensation: $27-$30/hour based on experience.
• A GMP background is key for this role.

This position is located in Branchburg, New Jersey, a vibrant community known for its scenic landscapes and close proximity to major metropolitan areas.

Benefits
PEAK's benefit offerings available for our associates include medical, dental, vision, Flexible Spending Account (FSA), Dependent Care Savings Account (DCA), and 401K plan. PEAK believes that taking care of our team is essential for success and we are proud to provide benefits that enhance both your well-being and your future. Additionally, our associates may be eligible for Paid Sick Leave as required by Federal, State, or local laws.  

Equal Opportunity Employer (EEO) 
PEAK Technical Staffing is committed to creating a diverse and inclusive environment and is proud to be an Equal Opportunity Employer. PEAK does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or veteran status, or any other characteristic protected by applicable law. All employment decisions are made based on qualifications, merit, and business need. We encourage all individuals to apply. 

Americans Disabilities Act (ADA) 
The physical and mental requirements described in this job description are representative of those that must be met by an employee to successfully perform the essential functions of the position. Reasonable accommodations may be made to enable qualified individuals with disabilities to perform the essential functions. Must be able to perform the essential physical functions of the position, including sitting, standing, walking, stooping, kneeling, and lifting up to 25 pounds, with or without reasonable accommodation. 

Candidate Privacy
To read our Candidate Privacy Information Statement, which explains how we will use your information, please navigate to https://peaktechnical.com/privacy-policy/ and https://peaktechnical.com/ca-residents-privacy-rights/  

AI Recruiting Disclosure 
We use AI-assisted tools to help review applications and compare your experience to job requirements, but all hiring decisions are made by human recruiters. You may request a human-only process or opt out of automated communication at any time. Required notices and our latest bias audit are available on our website: www.peaktechnical.com/ai-disclosure.