• Regulatory Compliance & Quality Systems Specialist / Sr. Specialist looking for 2-3 staff in this area, also with 10 years of experience supporting oper ations regulatory inspections, audits, and working within the
• Quality Systems of Change Control, Nonconformances and Corrective and Preventive Actions (CAPA), quality risk management.
• We could take on 1 person with less experience but need at least 5 years to be sure they can deliver at the level needed with minimal initial training / skill building.
• They should be familiar with the systems we utilize such as Trackwise, Veeva.

Requirements:

• Bachelor's degree in Science or Engineering.
• Familiar with US FDA CFRs, regulatory guidance, and cGMPs; prior experience in an audit, compliance or investigation/CAPA role.
• Experience with the following quality systems: risk management, change management; prior experience in a quality assurance role in a biologics manufacturing operation, or similar; could also have prior role in training/learning & performance within Quality; problem-solving techniques for root cause analysis in investigations.