Pay $50.00/HR to $70.92/HR. (Possible flex please let me know the rate you’d need for this role if so.)

Job Description:

• Site Quality technical and regulatory subject matter expert and technical leader for validation study methods, design, and regulatory requirements.
• Provide Quality Assurance oversight to Validation, Revalidation and Quality Risk Management projects to meet good business practices and the requirements of applicable Health Authorities.
• Maintain the compliance status of the assigned validation areas at a state of inspection readiness.
• Assist in the integration of the risk management program with quality systems including, but not limited to, Validation, CAPA, Change Control, APQR, Complaints, and Inspection Readiness.
• Provide technical review and approve validation deliverables ensuring proper study design and execution.

Qualifications:

• Bachelors Degree and 2 years of experience (open to senior level roles)
• GMP Experience
• Pharmaceutical experience preferred.
• Some Knowledge of Risk Assessment Methodology (PHA, FMEA, FTA), preferred.