More jobs:
Quality Engineer
Job in
Sandy, Salt Lake County, Utah, 84092, USA
Listed on 2026-06-02
Listing for:
millenniumsoft
Full Time
position Listed on 2026-06-02
Job specializations:
-
Quality Assurance - QA/QC
-
Healthcare
Data Scientist
Job Description & How to Apply Below
Roles & Responsibilities
- Develop, manage, and execute CAPA records aligned with regulatory and internal quality standards.
- Perform technical writing and detailed review of investigations, protocols, and reports.
- Ensure GMP compliance across quality and documentation deliverables.
- Identify compliance gaps, risks, and improvement opportunities.
- Collaborate with SMEs and cross-functional teams to support timely CAPA closure.
- Contribute to risk assessments and risk management activities using a science-based approach.
- Support inspection-ready documentation and quality processes.
- Maintain project timelines and deliverables.
- Experience in GMP-regulated environments preferred.
- Strong experience with CAPA processes and quality remediation activities.
- Experience in technical writing and document review within regulated industries.
- Familiarity with risk assessment and risk management practices preferred.
- ICH Q9 experience is an advantage.
- CAPA management
- GMP compliance
- Technical writing and document review
- Investigation and report review
- Risk assessment and risk management
- Cross-functional collaboration
- Problem-solving and analytical skills
- Time management and organization
- Bachelor's degree in Life Sciences, Pharmacy, Engineering, Quality, or related field preferred.
- Experience in pharmaceutical, biotech, or regulated manufacturing environments preferred.
- Ability to work independently and manage multiple deliverables.
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