Pharmaceutical QA Technician - RegulatoryAstrix • Chicago, Illinois, United States
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Pharmaceutical QA Technician - Regulatory
Astrix
- Chicago, Illinois, United States
- Chicago, Illinois, United States
Über
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
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Sprachkenntnisse
- English
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