Senior Quality Systems Engineer, GMP & Process Improvement

Compunnel Inc.

Salt Lake City (UT)

On-site

USD 110,000 - 150,000

Full time

5 days ago

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Job summary

Compunnel Inc. in Salt Lake City is seeking a Sr. Quality Systems Engineer to lead GMP-focused quality management responsibilities and drive continuous improvement within a pharmaceutical manufacturing environment.

You will oversee change control, quality documentation, validation/qualification activities, and data trend analysis, collaborating with Manufacturing, QA, MSAT, R&D, Supply Chain, and Regulatory functions.

Qualifications

Minimum 5 years of experience in Quality Systems and/or GMP compliance within a pharmaceutical manufacturing environment.
Strong experience with Quality Systems and Quality Assurance.
Experience with Change Control and quality documentation management.

Responsibilities

Manage and support Quality Management Systems (QMS) in a pharmaceutical manufacturing environment.
Lead Change Control activities from initiation through implementation, review, and final approval.
Host and facilitate the Change Control Review Board.
Review and approve SOPs, protocols, risk assessments, quality records, and other controlled documents.
Support GMP compliance and ensure quality systems meet regulatory requirements.
Support inspections and audits by FDA, EMA/MHRA, and other authorities.