Compliance Specialist

Responsible for assisting with the internal audit system to ensure production and support functions at the manufacturing facility operate in compliance with applicable regulations and standards.

Responsibilities:
- Assist with planning and conducting internal compliance audits of all operations within the facility.
- Support company and regulatory agency inspections (e.g., DEA, FDA).
- Follow up on audits to ensure action plans are developed and completed timely.
- Assist with management review and associated plant metrics.
- Support metrics collection and analysis for compliance-related corrective and preventive actions (CAPA’s).
- Responsible for supplier qualifications, including new suppliers, changes, and re-qualifications.

Qualifications:
- Bachelor’s Degree, preferably in Science or Engineering, or equivalent related work experience (required).
- 3+ years of biopharmaceutical experience.
- Quality Assurance/Regulatory Affairs/Compliance (preferred).
- Knowledge of pharmaceutical regulations and standards (e.g., CFR, MCA, DEA).
- Knowledge of plant and company-level procedures.
- Ability to evaluate quality, production, and support areas for compliance to GMPs/BOPs.
- Ability to identify and investigate problems and help resolve them.