Sr. Quality Systems Engineer
Job in
Provo, Utah County, Utah, 84605, USA
Listed on 2026-09-22
Listing for:
United Pharma
Full Time
position Listed on 2026-09-22
Job specializations:
-
Quality Assurance - QA/QC
Regulatory Compliance Specialist, QA Specialist - Analyst/Manager
Job Description & How to Apply Below
We are seeking a Senior Quality Systems Engineer with strong experience in Quality Systems, GMP compliance, and pharmaceutical manufacturing. This role will support and improve site Quality Management Systems (QMS), documentation management, continuous improvement, validation, qualification, and change management activities.
Key Responsibilities:- Support and maintain Quality Management Systems (QMS) and GMP compliance programs.
- Lead and oversee Change Control activities from initiation through implementation and final approval.
- Host and facilitate the Change Control Review Board.
- Review and approve SOPs, protocols, risk assessments, quality records, and other controlled documentation.
- Support documentation and records management for compliant facility shutdown planning and execution.
- Support continuous improvement programs, site KPIs, metrics, and Quality/Compliance initiatives.
- Support process, cleaning, and computer system validation, as well as equipment, facility, and utility qualification activities.
- Support Annual Product Reviews, metrics, and data trending.
- Help ensure facility operations remain compliant with cGMP, FDA, MHRA, EMEA, OSHA, EPA, DEA, and applicable company requirements.
Qualifications:
- Minimum 5+ years of Quality Systems / GMP / Compliance experience in pharmaceutical manufacturing.
- 3+ years of Quality Assurance experience within pharmaceutical production.
- Bachelor’s degree in Biology, Chemistry, or another scientific discipline preferred, or equivalent education/experience.
- Minimum 7 years of relevant progressive pharmaceutical industry experience preferred.
- Strong experience with Change Control and Quality Documentation Management.
- Experience reviewing and approving SOPs, protocols, risk assessments, and quality records.
- Strong technical writing, problem-solving, judgment, and decision-making skills.
- Ability to work independently and make higher-level quality/compliance decisions.
- Experience with pharmaceutical dosage-form manufacturing preferred.
- Experience supporting FDA/EMA/ANVISA or other Health Authority inspections preferred.
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