What are the responsibilities and job description for the Quality Assurance Technician-ClorDiSys position at Allentown LLC?
JOB TITLE: Quality Assurance Technician
FLSA STATUS: Non-Exempt
JOB TYPE: Full-time 100% On-Site attendance
DEPARTMENT: Regulatory Affairs and Quality Assurance
REPORTS TO: Senior Quality Engineer
JOB SUMMARY
The QA Technician supports quality assurance activities for medical device sterilization processes, ensuring that all operations are performed in accordance with validated parameters, regulatory requirements and customer specifications. This role is responsible for reviewing sterilization records, monitoring process controls, and supporting release decisions in compliance with the FDA regulations QMSR, CFR 210 and CFR 211 and applicable ISO standards (e.g., ISO 11135, ISO 11137, ISO 13485).
PRIMARY FUNCTIONS
- Review sterilization cycle records to verify compliance with the validated process parameters as specified in the internal procedures
- Perform detailed review of load documentation and supporting quality records
- Ensure completeness and accuracy of documentation prior to product release
- Support QA review and approval of sterilized product in accordance with internal procedures and customer requirements
- Verify critical process parameters (e.g., temperature, humidity, gas concentration, dose levels) are within validated ranges
- Perform pre-cycle and post-cycle software verification activities
- Act as an independent process verifier and/or witness as required
- Support environmental monitoring programs as required
- Ensure adherence to Good Manufacturing Practices (cGMP) and data integrity (ALCOA) requirements
- Promptly Triage, address 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 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 maintain 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 40lbs.
- 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.
EOE/AA/M/F/Veteran/Disability
Salary : $27 - $30