Senior Quality Systems Engineer

Description

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Senior Quality Systems Engineer

Contract: Salt Lake City, Utah, US

Salary Range: 45.00 - 50.00 | Per Hour

Job Code: 371730

End Date: 2026-10-17
Days Left: 21 days, 3 hours left

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Job Summary:
The Senior Quality Systems Engineer will support quality management systems within a pharmaceutical manufacturing environment, with emphasis on GMP compliance, Change Control, quality documentation, validation, and continuous improvement . This position will oversee quality system activities, review and approve controlled documentation, support audits and inspections, and collaborate across manufacturing and technical functions.

Key Responsibilities:

• Support and maintain Quality Management Systems and site Quality and Compliance programs.
• Lead Change Control activities from initiation through implementation, review, and approval.
• Provide records management and Change Control expertise supporting compliant site activities.
• Review and approve SOPs, protocols, risk assessments, and other quality records.
• Maintain quality systems in compliance with current Good Manufacturing Practices and applicable regulatory requirements.
• Support process and cleaning validation, computer system validation, and equipment, facility, and utility qualification activities.
• Support Annual Product Review, quality metrics, data trending, and continuous improvement initiatives.
• Participate in internal, partner, and regulatory inspections and audits as required.
• Support site quality projects, corporate standard assessments, and cross-functional quality initiatives.
• Collaborate with Operations, Manufacturing Science and Technology, Research and Development, Supply Chain, and Quality Control teams.
• Analyze complex quality issues and apply independent judgment and problem-solving to determine appropriate actions.

Required Qualifications:

• Bachelor's degree, preferably in a scientific discipline such as Biology, Chemistry, or a closely related field, or equivalent education and experience.
• Minimum five years of relevant Quality Systems and GMP/Compliance experience within a pharmaceutical manufacturing environment.
• Strong experience with Change Control and quality documentation management .
• Experience reviewing and approving SOPs, protocols, risk assessments, and quality records.
• Quality Assurance experience within pharmaceutical production.
• Strong knowledge of current Good Manufacturing Practices and pharmaceutical quality systems.
• Strong technical writing, documentation, and cross-functional communication skills.
• Ability to work independently, exercise sound judgment, and make higher-level quality decisions.
• Proficiency with MS Office and electronic quality/document management systems.

Preferred Qualifications:

• Seven or more years of progressive pharmaceutical industry experience.
• Direct experience with pharmaceutical manufacturing and various dosage forms.
• Experience supporting Health Authority inspections.
• Experience with TrackWise, Veeva, Learning Management Systems, Electronic Document Management Systems, and Enterprise Resource Planning systems .
• Project management and advanced presentation skills.
• Experience with quality metrics, data trending, and continuous improvement.

Benefits:

The Company offers the following benefits for this position, subject to applicable eligibility requirements: medical insurance, dental insurance, vision insurance, 401(k) retirement plan, life insurance, long-term disability insurance, short-term disability insurance, paid parking/public transportation, paid time off, paid sick and safe time, hours of paid vacation time, weeks of paid parental leave, and paid holidays annually - as applicable.

Pay Range: $45/hr - $50/hr

Job Requirement

• Quality Systems
• GMP Compliance
• Change Control
• Quality Assurance
• Pharmaceutical Manufacturing
• Technical Writing
• SOP Review
• Risk Assessments
• Quality Documentation
• TrackWise
• Veeva
• Validation

Reach Out to a Recruiter

• Recruiter
• Email
• Phone
• Gagandeep Singh
• View email address on click.appcast.io
• View phone number on click.appcast.io

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