Compliance Specialist

📋 Description

• Review quality critical alarms and NRSR.
• Review J&Cs.
• Enter metrics into database.
• Initiate and investigate deviations for non-conformance.
• Containment assessment for deviations (off-hours).
• Provide off-hours support for batch record issuance.
• Back-up QA Manager.
• Other duties as assigned.

🎯 Requirements

• Bachelor's degree in a scientific field with 4-6 years in quality or cGMP.
• Master's degree in a scientific field with 2 years' experience in above.
• 2 years of experience in a quality role.
• Knowledge of external agency regulations (FDA, EMA, etc.)
• Strong computer, verbal and written communication skills.
• Experience in quality systems.
• Experience in leading cross-functional teams.
• Experience with TrackWise or equivalent system.
• Proficient in Microsoft Office.