Compliance Specialist

Added
11 days ago
Type
Full time
Salary
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Related skills

gmp capa fda dea internal audits
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📋 Description

  • Responsible for assisting with the internal audit system that will assure that all production and
  • Assists with planning and conducting internal compliance audits of all operations within the
  • Provides support with company and regulatory agency inspections (e.g., DEA, FDA).
  • Follow up on audits to ensure 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 CAPAs.

🎯 Requirements

  • Bachelor’s Degree, preferably in Science or Engineering, or equivalent related work experience is
  • 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.

🎁 Benefits

  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick)
  • 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
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