Overview
Pharmaceutical QA Technician – Regulatory Jobs in Chicago, IL at Astrix
Title: Pharmaceutical QA Technician – Regulatory
Company: Astrix
Location: Chicago, IL
Pay Rate Low: 30.00 | Pay Rate High: 35.00
Our client is one of the largest global suppliers of antiseptic products. With their recent growth they have expanded into a 2nd location in the Illinois market. They pride themselves by making sure they have the best equipment for their team to utilize. They are hiring a QA Technician to join their growing team ASAP!
Schedule: Mon-Fri 8a-4:30p
Type of Job: Temp to hire
Responsibilities
- Ensure adherence to FDA, EMA, ICH, and other applicable regulatory requirements
- Support preparation and review of regulatory submissions, including INDs, NDAs, ANDAs, and supplements
- Interpret and apply regulatory guidelines to quality systems and operations
- Lead and/or support deviation, OOS, OOT, and complaint investigations
- Perform root cause analysis using structured methodologies (e.g., 5 Whys, Fishbone)
- Develop and track CAPAs to ensure timely and effective resolution
- Participate in internal, external, and regulatory audits (FDA, clients, notified bodies)
- Review and approve quality documentation (SOPs, batch records, protocols, reports)
- Ensure compliance with data integrity standards (ALCOA+ principles)
- Support change control processes and assess regulatory impact
Requirements
- Bachelor’s degree preferred, High School diploma or equivalent required
- Experience in the pharmaceutical industry with reviewing batch records, regulatory work, audits, and investigations
We strongly encourage candidates who have some of the skills to apply. We look forward to a conversation to learn more about you!
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