- Longmont, Colorado, United States
- Full-time · Senior
- $94K–$109K per year
- 2–4 years
Supports the Quality Management System (QMS) and Document Management System (DMS) in a GMP regulated environment, ensuring compliance with SOPs, GMP/GLP standards and client requirements.
Compensation
The hiring range in Colorado for this position is $93,750/year - $108,750/year and is eligible for a 4% annual target bonus.
Responsibilities
- Perform independent quality evaluation and release of support documentation, materials, products, equipment, and/or facilities
- Ensure testing/manufacturing performed per approved SOPs/methods/protocols and comply with specifications
- Participate in internal, client and/or regulatory audits
- Support quality events and root cause analysis
- Develop, implement, and maintain procedures and policies to comply with FDA, EU, and ICH requirements
Requirements
- Bachelor's or equivalent in a related field