Senior Specialist, QA Compliance

Company Description

About Abb Vie

Abb Vie'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 including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about Abb Vie, please visit us at  Follow @abbvie on Linked In, Facebook, Instagram, X and You Tube.

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.

• 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 (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. Creates compliance performance metrics.
• 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.
• Builds internal auditing process.
• Updates documentation to ensure it is up to date and compliant with standards.
• Supports change management efforts across the team.

• 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.

• 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 until paid and may be modified at the Company’s sole and absolute discretion, consistent with applicable law.

Abb Vie 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.

US & Puerto Rico only - to learn more, visit

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