Quality Auditor - Radiopharmaceuticals
Carmel, INAll locationsCarmel, INIndianapolis, INChicago, ILChurubusco, INWarren, INFort Wayne, INSouth Bend, INEvansville, IN On-site
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About the role
For nearly 30 years, SQA Services has been a leading provider of managed supplier quality services, offering audits, assessments, remote surveillance, corrective actions, remediation, inspections, and engineering solutions to manufacturers across all industries. We deliver these services by deploying a network of highly skilled associates based throughout the United States and in over 90 countries worldwide, ensuring rapid on-site support at your supplier locations. Our associates are expert quality assurance professionals with extensive experience and local expertise, enabling us to represent our clients on-demand and with greater speed and efficiency than our competitors. We’re hiring a Supplier Quality Auditor who has experience working with radiopharmaceuticals. This is a contract opportunity in which you will perform supplier quality audits at various suppliers in the Midwest. These audits are generally 1-2 days long. You are given the flexibility to accept or reject these assignments according to your own availability.
What you'll bring
- 5+ years of hands-on audit experience in pharmaceutical, medical device, and/or biologics industries
- Has been the lead auditor in at least 10 audits
- Direct audit experience to 21 CFR part 210/211, EU Vol 4, and Canada GMP
- Strong communication and writing skills
- Proven ability to deescalate workplace conflicts effectively
- Ability to adapt to new technology and software.
- Willingness to travel regionally
- Direct audit experience to ISO 17025, ISO 15378, IPEC GDP, ICH Q7, ISO 13485, 21 CFR 100, and/or 21 CFR 507
- ISO certifications are a plus but not mandatory