Quality Engineer 3_26-02471
Full-time
Sunrise Systems Inc
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)
Must Have
- 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.
Vacancy posted 2 days ago
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