What are the responsibilities and job description for the Senior Quality Engineer - Onsite (Urgent Need) position at MillenniumSoft Inc?
Job Title - Engr 3, Quality
Job Location - 9450 South State Street, Sandy, Utah, United States of America, 84070
Duration: 6 Months
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:
Job Location - 9450 South State Street, Sandy, Utah, United States of America, 84070
Duration: 6 Months
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)