Compliance Officer (Inspection Coordinator)

📋 Description

• Implement and maintain a functional internal audit system to assure compliance with applicable
• Plan and conduct internal compliance audits of all operations within the facility.
• Serve as plant administrator for all company and regulatory agency (DEA, FDA) inspections.
• Convey violations to plant management/supervisory personnel via written reports or audit wrap-up
• Follow up on audits to ensure action plans are developed and completed timely.
• Keep current with regulatory requirements and disseminate/interpret them to plant personnel.

🎯 Requirements

• Bachelor's Degree, preferably in Science or Engineering, or equivalent related work experience.
• 3+ years of Biopharmaceutical experience.
• Quality Assurance/Regulatory Affairs/Compliance experience required.
• Knowledge of regulations and standards for pharmaceuticals (e.g., CFR, MCA, DEA).
• Demonstrate extensive knowledge of plant and company level procedures.
• Ability to evaluate quality, production and support areas for compliance to GMPs, BOPs, etc.

🎁 Benefits

• Comprehensive package of benefits including paid time off (vacation, holidays, sick)
• Eligible to participate in short-term incentive programs.
• Compensation range: $96,500 - $183,500 per year.