Senior Specialist, QA Compliance

Role Summary

Responsible for assisting with the internal audit system to ensure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards. This role supports planning, execution, and follow-up of internal audits and inspections to ensure ongoing compliance and effective CAPAs.

Responsibilities

• Assists with planning and conducting internal compliance audits of all operations within the facility. Helps the team to become more proactive in preparing for audits.
• Provides support with company and regulatory agency inspections (e.g., DEA, FDA).
• 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. Creates compliance performance metrics.
• Provides support in the metrics collection and analysis for compliance-related corrective and preventive actions (CAPAs).
• Responsible for supplier qualifications including new suppliers, changes and re-qualifications.
• Builds internal auditing process.
• Updates documentation to ensure it is up to date and compliant with standards.
• Supports change management efforts across the team.

Qualifications

• Bachelor’s Degree, preferably in Science or Engineering, or equivalent related work experience is required.
• 5+ years of experience in a cGMP related industry or clinical setting
• 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.
• Ability to identify and investigate problems and help to resolve them.