Biopharma QA Compliance Auditor

Allergan; North Chicago (IL); On-site; USD 90,000 - 115,000; Full time

Job summary

AbbVie seeks a Compliance Auditor to support internal audit programs ensuring manufacturing operations meet regulatory standards. Responsibilities include planning and conducting audits, supporting FDA/DEA inspections, and tracking corrective actions within the plant.

The role requires a Bachelor's in Science or Engineering with 3+ years Biopharmaceutical experience and knowledge of CFR/DEA regulations. Strong analytical skills and attention to GMPs are essential.

Qualifications

• Bachelor's Degree in Science or Engineering or equivalent related work experience.
• 3+ years of Biopharmaceutical experience.
• 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.

Responsibilities

• Assists with planning and conducting internal compliance audits of all operations within the facility.
• 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 preventive actions (CAPA's).
• Responsible for supplier qualifications including new suppliers, changes and re-qualifications.

Education

Bachelor's Degree in Science or Engineering

Equivalent related work experience

Job description

AbbVie seeks a Compliance Auditor to support internal audit programs ensuring manufacturing operations meet regulatory standards. Responsibilities include planning and conducting audits, supporting FDA/DEA inspections, and tracking corrective actions within the plant.

The role requires a Bachelor's in Science or Engineering with 3+ years Biopharmaceutical experience and knowledge of CFR/DEA regulations. Strong analytical skills and attention to GMPs are essential.