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.
• Supports metrics collection and analysis for compliance-related corrective and preventive actions (CAPAs).
• Assists with supplier qualifications, including new suppliers, changes, and re-qualifications.

Qualifications

• Bachelor’s Degree, preferably in Science or Engineering, or equivalent related work experience is required.
• 3+ years of Biopharmaceutical experience, with Quality Assurance/Regulatory Affairs/Compliance preferred.
• Knowledge of regulations and standards for pharmaceuticals (e.g., CFR, MCA, DEA).
• 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 resolve them.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law: The compensation range described below is the range of possible base pay compensation that the Company believes in good faith 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, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance, and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs.

Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains 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 our community. Equal Opportunity Employer/Veterans/Disabled.

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US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html