Engr 3, Quality
Job Location:
Monthly Salary:
Posted on:
21 days ago
Posted on:
Vacancies:
1 Vacancy
Vacancies:
Job Summary
Bill rate is $60 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)
Core Hours will be between 8 am-5pm Mon-Fri
