Compliance Officer (Inspection Coordinator)

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

Responsibilities:
- Plan and conduct internal compliance audits of all facility operations.
- Serve as plant administrator for company and regulatory agency inspections (e.g., DEA, FDA).
- Report violations to plant management/supervisory personnel via written reports and/or audit wrap-up discussions.
- Follow up on audits to ensure action plans are developed and completed timely.
- Maintain current knowledge of regulatory requirements and disseminate/interpret requirements for plant personnel.
- Consult with plant personnel on regulatory requirements and compliance topics.
- Own plant management review and associated metrics.
- Coordinate/administrate manufacturing materials and pest control programs.
- Coordinate and facilitate major plant quality improvement projects.
- Collect and analyze metrics for compliance-related corrective and preventive actions (CAPA).

Qualifications:
- Bachelor’s Degree (preferably Science or Engineering) or equivalent related work experience (required).
- 3+ years of biopharmaceutical experience.
- Quality Assurance/Regulatory Affairs/Compliance experience (required).
- Knowledge of pharmaceutical regulations/standards (e.g., CFR, MCA, DEA).
- Extensive knowledge of plant and company procedures.
- Ability to evaluate quality/production/support areas for compliance with GMPs/BOPs.
- Strong decision-making.
- Ability to anticipate problems, identify/investigate issues, and recommend solutions.