Quality Control Engineer - [21 CFR, CAPA Required]

Job Description

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.

• 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
• Additiona ldesired 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)

Requirements

• Strong knowledge of 21 CFR Part 211 requirements
• Demonstrated expertise in technical writing and document review within a regulated environment

Qualifications

• Familiarity with ICH Q9 principles

Skills

• Technical writing and critical review of investigations, protocols, and reports
• 21 CFR Part 211 knowledge
• Risk assessment and risk management
• Structured, science- and risk-based approach to risk assessments

Benefits

• Not specified

Pay

• Not specified

Schedule

• 1st Shift