Compliance Specialist

Compliance Auditor

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio.

Responsible for assisting with the internal audit system that will assure that all production and support functions at the manufacturing facility operate in compliance with all applicable regulations and standards.

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.

Qualifications:

• Bachelor's Degree, preferably in Science or Engineering, or equivalent related work experience is required.
• 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.
• Ability to identify and investigate problems and help to resolve them.

Additional Information:

• 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.

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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Pay Range: $75000 - 142500 USD

Where We Work:

Role is exclusively performed at a site or office and onsite presence is required. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.