QUALITY ENGINEER JOB LISTING

Position Summary:

• Lead and support deviation, OOS, and CAPA investigations.
• Perform root cause analysis using structured methodologies (e.g., Fishbone, 5-Why, FMEA).
• Ensure investigations are thorough, timely, scientifically sound, and well-documented.
• Provide quality oversight for process validations and equipment qualifications.
• Support FDA inspection readiness and internal audits.
• Conduct risk assessments and drive continuous improvement initiatives.
• Support change control assessments including risk evaluations for manufacturing, analytical, and packaging changes.
• Support supplier qualification process.

Qualifications:

• Bachelor’s degree in Engineering, Chemistry, or related field.
• 3+ years of pharmaceutical or OTC manufacturing experience.
• Strong knowledge of FDA cGMPs (21 CFR 210/211).
• Experience with investigations, root cause analysis, and CAPA.
• Excellent communication and technical writing skills.

Why Join Us?:

• Opportunity to make a direct impact on product quality and consumer safety.
• Collaborative, quality-focused culture.
• Competitive compensation and benefits.
• Career growth in an FDA regulated OTC manufacturing environment.

If you are a detail-oriented professional who thrives in a GMP-regulated environment and enjoys solving complex quality challenges, we encourage you to apply.

Job Type: Full-time

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Health insurance
• Paid time off

Work Location: In person