Quality Assurance & Compliance Specialist – Biotech GMP

University of Colorado Anschutz; Aurora (CO); On-site; USD 63,000 - 90,000; Full time

Benefits offered by this job

Medical plans

Dental plans

Disability insurance

Life insurance

Vision insurance

Retirement plan 401(a)

Paid time off

Vacation 22 days/year

Sick days 15 days/year

Holidays 15 days/year

Tuition benefit

ECO Pass

Job summary

The University of Colorado Anschutz’s Gates Biomanufacturing Facility (GBF) in Aurora, CO, seeks a full-time Quality Assurance Associate II or Engineer I to support GMP and non-GMP batch release for biologics and cell therapies in a Phase I setting.

The role covers batch record review, material release, equipment qualifications, eQMS improvements, and QA oversight to ensure compliant releases and continuous quality improvements in a fast-paced academic-industry environment.

Qualifications

• Bachelor's degree in Biological Sciences or Engineering or related field.
• 2+ years of GMP QA operational experience for pharma/biologics/cell therapies.

Responsibilities

• Review Batch Records, In-Process and Release data related to GMP and Non-GMP releases.
• Review and release incoming materials and equipment qualifications (IQ/OQ/PQ).
• Support remediation of eQMS systems including policy and SOP documents.

Skills

GMP QA oversight

Biological Sciences or Engineering

Education

Bachelor's degree in Biological Sciences or Engineering

Tools

IQ/OQ/PQ

Job description

The University of Colorado Anschutz’s Gates Biomanufacturing Facility (GBF) in Aurora, CO, seeks a full-time Quality Assurance Associate II or Engineer I to support GMP and non-GMP batch release for biologics and cell therapies in a Phase I setting.

The role covers batch record review, material release, equipment qualifications, eQMS improvements, and QA oversight to ensure compliant releases and continuous quality improvements in a fast-paced academic-industry environment.