Quality Engineer 3

Quality Engineer 3
Sandy, UT
Duration: 6-month
Shift: 8 am-5pm Mon-Fri
 
Job Description:

• 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)

 
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

 

At SPECTRAFORCE, we are committed to maintaining a workplace that ensures fair compensation and wage transparency in adherence with all applicable state and local laws. This position's starting pay is: $37.50/hr.