Engr , Quality

Engr 3, Quality | Sandy, Utah, United States [About the Role]
Join a leading quality remediation initiative as an Engr 3, Quality in Sandy, UT. This is a part-time, temporary contractor position (20-30 hours/week, 6-month duration) ideal for an experienced GMP professional with a deep understanding of 21 CFR Part 211. Play a pivotal role in supporting CAPA deliverables, technical writing, and regulatory compliance. Collaborate with cross-functional teams and make a significant impact on organizational quality standards.

[Responsibilities]

- Develop and execute CAPA records to meet internal quality and regulatory requirements
- Author, review, and refine technical documents, including investigations, protocols, and reports
- Apply 21 CFR Part 211 expertise to ensure full GMP compliance and proactively identify risks or gaps
- Partner with subject matter experts and functional groups to ensure timely CAPA closure and project delivery
- Contribute to risk assessments using a structured, science-based approach aligned with ICH Q9 principles
- Maintain inspection-ready documentation and support continuous quality improvement

[Required Skills and Experience]

- 15+ years in GMP-regulated environments with proven CAPA management experience
- Advanced technical writing and document review skills within pharmaceutical or related industries
- In-depth knowledge of 21 CFR Part 211 and strong compliance acumen
- Independent self-starter with demonstrated ability to deliver high-quality outputs on schedule
- Excellent collaboration and communication abilities

[Preferred Skills]

- Experience applying ICH Q9 for risk assessment and management
- Direct involvement in large-scale quality remediation projects
- Strong project management capabilities in regulated settings

[Benefits]

- Competitive bill rate: $60/hour
- Flexible part-time schedule (20-30 hours/week, core hours 8 am-5 pm, Mon-Fri)
- Opportunity to contribute to a high-impact quality initiative
- Expand your expertise in regulatory compliance and risk management
- Collaborate with industry-leading professionals in a dynamic environment

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How to Apply

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Ready to elevate your career as a quality expert? Submit your resume and a brief cover letter detailing your experience with CAPA and GMP compliance. Qualified candidates will be contacted for an interview promptly.

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