Job Description

Job Description

Job Description

Job Title: Quality Engineer 3
Job Id: 26-02471
Location: Sandy, UT
Duration: 06 Months Contract
Position Type: Hourly Contract Position (W2 only)

• 21 CFR Part 210/211
• BS in scientific/technical field (or equivalent experience)
• Direct CAPA authoring
• Investigation writing
• Pharmaceutical/Drug Manufacturing
• Technical Review

Nice To Have  

• Cleaning Validations
• Equipment Validation, Transfer, and Qualification
• ICH Q9
• OOS Investigations
• Supplier Assurance

Job Description  

• Core Hours will be between 8 am-5pm Mon-Fri
• Temporary (6-month) contract
• GMP professional to support CAPA deliverables as part of a broader quality remediation initiative, bringing strong knowledge of 21 CFR Part 211 requirements and demonstrated expertise in technical writing and document review within a regulated environment. 
• The ideal candidate will be capable of independently driving high-quality, inspection-ready outputs while partnering with cross-functional teams and contributing to a risk-based approach to compliance, with additional value placed on familiarity with ICH Q9 principles

Key capabilities include:  

• Develop and execute CAPA records, ensuring alignment with regulatory expectations and internal quality standards
• Perform thorough technical writing and critical review of investigations, protocols, and reports
• Apply 21 CFR Part 211 knowledge to ensure GMP compliance across deliverables and identify potential risks or gaps
• Collaborate with SMEs and functional teams to drive timely closure of CAPAs and maintain project timelines
• Additional desired skills in risk assessment and risk management to contribute to or author/review risk assessments using a structured, science- and risk-based approach (ICH Q9 experience preferred)

Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.

Company Description

Founded in 1990, Sunrise Systems is an award winning IT/Professional Staffing firm to Fortune 500 and State/Local Government Agencies.

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