Compliance Officer (Inspection Coordinator)

About the role

Responsible for implementing and maintaining a functional internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards.

Responsibilities

• Responsible for Regulatory Compliance at the plant level which includes planning and conducting internal compliance audits of all operations within the facility.
• Serve as plant administrator for all company and regulatory agency (i.e. DEA, FDA) inspections.
• Convey all violations to appropriate plant management/supervisory personnel via written reports and/or open discussions in audit wrap-up meetings.
• Follow up on audits to assure that action plans are developed and completed in a timely fashion.
• Keep current with all regulatory requirements and disseminate and interpret all regulatory requirements to plant personnel in a timely and accurate fashion.
• Consult with plant personnel on regulatory requirements and compliance related topics.
• Responsible for management review and associated metrics for the plant.
• Administrate/coordinate the plant manufacturing materials and pest control programs.
• Coordinate and facilitate major plant quality improvement projects at the plant or company level.
• Perform process of metrics collection and analysis for compliance-related corrective and preventive actions (CAPA's).

Qualifications

• Bachelor's Degree, preferably in Science or Engineering, or equivalent related work experience is required.
• 3+ years of Biopharmaceutical experience.
• Quality Assurance/Regulatory Affairs/Compliance experience required.
• Knowledge of regulations and standards for pharmaceuticals (e.g. CFR, MCA, DEA).
• Able to demonstrate extensive knowledge of plant and company level procedures.
• Ability to evaluate quality, production and support areas for compliance to GMPs, BOPs, etc.
• Strong decision making.
• Ability to anticipate problems, identify and investigate them, and make recommendations to help resolve.

Benefits

• Paid time off (vacation, holidays, sick).
• Medical/dental/vision insurance.
• 401(k) to eligible employees.
• Eligibility to participate in short-term incentive programs.