TempeFull TimeEngineering
Remotely
regulatory compliancecapagmpfdainternal auditsdeasupplier qualificationbops
Job Description
📋 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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