Compliance Specialist, Quality Assurance - QA​/QC

Job Description

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.
• 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 (CAPAs).
• Responsible for supplier qualifications including new suppliers, changes, and re‑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, or Compliance experience is 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 to resolve them.

• Comprehensive package of benefits including paid time off (vacation, holidays, sick), medical, dental, vision insurance and 401(k) for eligible employees.
• Eligibility to participate in short‑term incentive programs.

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.