Senior Quality Systems Engineer — Onsite (Salt Lake City)

eTeam; Salt Lake City (UT); On-site; USD 100,000 - 140,000; Full time

Job summary

eTeam seeks a Sr. Quality Systems Engineer in Salt Lake City to support the QMS, documentation management, and CGMP compliance. The role oversees change management, annual product reviews, and data trending, interfacing with Operations, MST, R&D, Supply Chain and QA.

This senior role requires extensive QA in pharmaceutical manufacturing, strong technical writing, and the ability to make high-level decisions independently. Onsite work on a 24+ month contract is required.

Qualifications

• Bachelor’s degree in science; 7 years pharmaceutical experience.
• Minimum 3 years QA in pharmaceutical production.
• Experience with Health Authority inspections (FDA/EMA) preferred.
• Project management and advanced presentation skills preferred.

Responsibilities

• Develops and executes annual projects to meet site KPIs and quality goals.
• Hosts Change Control Review Board and oversees change activities.
• Provides records management and supports compliant shutdown planning.
• Ensures GMP and regulatory compliance in operations and facilities.
• Reviews SOPs, protocols, risk assessments and quality records.
• Improves and maintains quality systems for CGMP compliance.
• Supports cross-functional site initiatives and training compliance.

Skills

Quality Systems

GMP Compliance

Change Control

Documentation Management

SOP Review

Risk Assessments

Quality Records

Technical Writing

Communication Skills

Independent Decision-Making

Senior level

Education

Bachelor's Degree in a scientific discipline

Tools

TrackWise

Veeva

MS Office

LMS

EDMS

ERP Systems

Job description

eTeam seeks a Sr. Quality Systems Engineer in Salt Lake City to support the QMS, documentation management, and CGMP compliance. The role oversees change management, annual product reviews, and data trending, interfacing with Operations, MST, R&D, Supply Chain and QA.

This senior role requires extensive QA in pharmaceutical manufacturing, strong technical writing, and the ability to make high-level decisions independently. Onsite work on a 24+ month contract is required.