Pharmaceutical QA Technician – Regulatory Full Time NEW

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!

INDBH