Compliance Specialist

Responsibilities

• Aids in planning and conducting internal compliance audits of all operations within the facility.
• Supports company and regulatory agency (e.g., DEA, FDA) inspections.
• Follows up on audits to ensure action plans are developed and completed promptly.
• Assists with management reviews and associated metrics for the plant.
• Collects and analyzes metrics for compliance-related corrective and preventive actions (CAPAs).
• Supports supplier qualification processes, including new suppliers, changes, and re-qualifications.

Qualifications

• Bachelor’s degree, preferably in Science or Engineering, or equivalent related work experience required.
• At least 3 years of biopharmaceutical experience, with Quality Assurance/Regulatory Affairs/Compliance preferred.
• Knowledge of pharmaceutical regulations and standards (e.g., CFR, MCA, DEA) is essential.
• Some knowledge of plant and company-level procedures is required.
• Ability to evaluate quality, production, and support areas for compliance with GMPs, BOPs, etc.
• Ability to identify and resolve problems effectively.

Additional Information

Applicable only to applicants applying to positions in locations with pay disclosure requirements under state or local law. The compensation range described is the range the Company believes it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location. AbbVie offers a comprehensive package of benefits including paid time off, medical/dental/vision insurance, and a 401(k) plan to eligible employees. This job is eligible to participate in short-term incentive programs. Note: No amount of pay is considered wages or compensation until earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or other forms of compensation and benefits remain in the Company's sole and absolute discretion unless and until paid and may be modified at the Company's sole and absolute discretion, consistent with applicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, and serving its community. Equal Opportunity Employer/Veterans/Disabled. For more information, visit here. For US & Puerto Rico applicants seeking reasonable accommodations, click here.