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.
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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.
US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
Dental insuranceVision insurance401(k)Paid time offPerformance bonus
Additional Information
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.
Abbvie · North Chicago, IL