Compliance Specialist

Compliance Specialist responsible for reviewing quality critical alarms and NRSR, reviewing J&Cs, metric entry into database, initiating and investigating deviations, and providing off-hour support. The role also involves functioning as a back-up for QA Manager and performing other assigned activities.

Requirements

• Bachelor’s Degree in a scientific field
• 4-6 years experience in a Quality and/or other cGMP related field
• 2 years of experience in a Quality role
• Knowledge in external agency regulations (FDA, EMA, etc.)
• Strong computer, verbal and written communication skills
• Experience in quality systems
• Experience in leading cross functional team
• Experience with Trackwise or equivalent system
• Proficient in Microsoft Office