Colorado State University
Quality Assurance Specialist III
🇺🇸 Fort Collins, CO
🕑 Full-Time
💰 $95K - $115K
💻 Quality Assurance
🗓️ July 28th, 2025
Edtech.com's Summary
- Lead internal and external audits for regulated research activities ensuring compliance with GLP, sponsor protocols, and regulatory standards.
- Maintain quality systems and infrastructure for GLP compliance at the Preclinical Surgical Research Laboratory and Orthopedic Bioengineering Research Laboratory.
- Review documentation supporting process validation and product review throughout regulated research stages.
- Coordinate with QA managers and Test Facility Managers to plan and manage processes assessing GLP activities at CSU.
- Focus on continuous improvement, design controls, validations, and adherence to regulations and industry guidelines.
- Required skills include experience in GLP operations, pharmaceuticals, biologics, medical devices, FDA and regulatory audits, and academic and industry settings.
- Associate degree with 10+ years of relevant QA or compliance experience in biologics, pharmaceutical, or medical device industries.
- Preferred qualifications include RQAP certification and experience in experimental surgical veterinary medicine.
- Annual salary range from $95,000 to $115,000.
- Collaborate with CSU IRB, IACUC, and IBC on GLP and regulatory compliance issues and contribute to policy development and training.
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