Senior Quality Systems Engineer - Onsite GMP & Compliance Lead

Kelly Services

Salt Lake City (UT)

On-site

USD 93,000 - 104,000

Full time

2 days ago
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Job summary

Kelly Science & Clinical is seeking a Sr. Quality Systems Engineer in Salt Lake City, on-site. The role focuses on supporting QMS documentation, change control, and CGMP compliance within a pharmaceutical manufacturing environment.

The candidate should have a bachelor’s degree in a science field with 7+ years of progressive pharma experience and at least 3 years in QA. The job requires strong technical writing and cross-functional collaboration across departments.

Qualifications

  • Bachelor’s Degree in science or related field with 7+ years in pharma.
  • Minimum 3 years’ experience in Quality Assurance in pharmaceutical production.
  • Experience with Health Authority inspections (FDA/EMA) preferred.

Responsibilities

  • Support quality management systems (QMS) documentation and records.
  • Lead change control activities and review boards from initiation to approval.
  • Approve SOPs, protocols, risk assessments, and quality records.
  • Maintain CGMP compliance across processes, equipment, and facilities.
  • Collaborate with Operations, R&D, and Quality Control to drive improvements.

Skills

Quality Systems
GMP/Compliance
Change Control
SOPs & Protocols
Technical Writing
Independent Problem-Solving
Cross-Functional Communication
Senior-Level Decision-Making

Education

Bachelor’s Degree in Science
7+ years pharmaceutical experience
Quality Assurance in pharma

Tools

TrackWise
Veeva
MS Office
LMS
EDMS
ERP systems

Job description

Kelly Science & Clinical is seeking a Sr. Quality Systems Engineer in Salt Lake City, on-site. The role focuses on supporting QMS documentation, change control, and CGMP compliance within a pharmaceutical manufacturing environment.

The candidate should have a bachelor’s degree in a science field with 7+ years of progressive pharma experience and at least 3 years in QA. The job requires strong technical writing and cross-functional collaboration across departments.

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