Compliance Specialist
AbbVie•Tempe, AZ
•$75,000 - $142,500•Onsite
About The Position
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.
Requirements
- Bachelor’s Degree, preferably in Science or Engineering, or equivalent related work experience is required.
- 3+ years of Biopharmaceutical experience
- 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.
Nice To Haves
- Quality Assurance/Regulatory Affairs/Compliance is preferred
Responsibilities
- 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 (CAPA’s).
- Responsible for supplier qualifications including new suppliers, changes and re-qualifications.
Benefits
- paid time off (vacation, holidays, sick)
- medical/dental/vision insurance
- 401(k)
- short-term incentive programs
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
