Quality Engineer - Onsite (Part time 20 - 30 hours per week)

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 — 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
• 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)

Responsibilities

• 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.

Requirements

• Strong knowledge of 21 CFR Part 211 requirements and demonstrated expertise in technical writing and document review within a regulated environment
• Experience in developing and executing CAPA records, ensuring alignment with regulatory expectations and internal quality standards
• Ability to perform thorough technical writing and critical review of investigations, protocols, and reports
• Experience applying 21 CFR Part 211 knowledge to ensure GMP compliance across deliverables and identify potential risks or gaps
• Experience collaborating with SMEs and functional teams to drive timely closure of CAPAs and maintain project timelines
• 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)

Qualifications

• Not specified

Skills

• Technical writing
• Document review
• Regulated environment experience
• 21 CFR Part 211 knowledge
• Risk assessment and risk management
• ICH Q9 principles

Benefits

• Not specified

Pay

• Not specified

Schedule

• 1st Shift