QA Compliance Specialist

📋 Description

• Assists with planning and conducting internal compliance audits of all operations within the
• Provides support with company and regulatory agency (i.e. DEA, FDA) inspections.
• Follow up on audits to assure that action plans are developed and completed in a timely fashion.
• Assist with management review and associated metrics for the plant.
• Provides support in the metrics collection and analysis for compliance-related corrective and
• Responsible for supplier qualifications including new suppliers, changes and re-qualifications.

🎯 Requirements

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

🎁 Benefits

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