Senior Specialist, Quality Assurance — cGMP

Job overview

The Senior Specialist, Quality Assurance — cGMP role is primarily onsite in Boulder, CO, with remote work when appropriate. The salary range is $105,060–$129,780 per year. Umoja Biopharma develops immunotherapy treatments for cancer, and this role supports new product introduction and routine current Good Manufacturing Practice operations. The specialist provides independent quality oversight and subject-matter expertise, reviews and approves controlled documentation, supports investigations and change implementation, and provides on-the-floor quality support. The role helps ensure operations meet approved procedures, internal quality standards, and applicable regulatory requirements while improving site quality systems.

What you'll do

• Provide quality oversight and direction during site start-up and routine cGMP operations
• coordinate with functional departments to support compliance
• advise on site material controls
• review and approve material specifications and perform material disposition
• review and approve master batch records, work instructions, SOPs, specifications, deviations, CAPAs, and change controls
• develop and manage quality-system metrics
• support batch record review and product disposition processes
• and provide on-the-floor quality oversight and real-time support.

What we're looking for

Skills & competencies

quality assurance

senior specialist

cgmp

boulder co

umoja biopharma

$105,060–$129,780/year

biopharma

quality systems

batch records

capa

change controls

onsite

occasional nights and weekends

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, and vision plans
• 401(k) with 100% match up to the first 4% deferral
• paid time off
• commuter benefits
• and cell phone stipend.

Why this role

The posting describes a cancer immunotherapy biotech mission and cross-functional quality work supporting new product introduction and cGMP operations.

About the employer

Umoja Biopharma is hiring for this role. Industry: Research and Development in Biotechnology (except Nanobiotechnology). Sector: 54.