Senior Specialist, QA Compliance

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. 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 (CAPAs).
• 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.

Qualifications :

• Bachelors 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.

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 Companys sole and absolute discretion unless and until paid and may be modified at the Companys 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. 

US & Puerto Rico only - to learn more visit  & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:

Work :

No

Employment Type :

Full-time