Compliance Specialist - Audit , GMP

Responsibilities

• Host client audits and coordinate with clients.
• Cook up audit responses.
• Perform internal audits as required.
• Perform quality review and approval of documents, data, protocols, and/or reports.
• Maintain quality databases and support quality systems.
• Aid in the development of SOPs or other quality documents as needed.
• Consult with clients on all levels of regulatory issues.
• Serve as an effective member of the Compliance team and serve as a mentor in area of expertise.
• Comply with company policies and SOPs.
• Aid in quality improvement initiatives as needed.
• Ensure timely completion and compliance with cGMP and all other relevant company training requirements.

Qualifications

• Bachelor’s degree in Chemistry, Biology, or related field with 3+ years of GMP related experience, or Master’s degree in related field with 1+ years of related experience, or equivalent educational and work experience.
• Audit hosting experience preferred.
• Client facing experience a plus.
• Supplier management experience in pharmaceutical industry is a plus.
• Good knowledge of regulations and SOPs applicable to area of responsibility and keeps abreast of new regulations and regulatory guidance in areas of expertise.
• Good written and oral communication and presentation skills.
• Good computer skills and knowledge of Microsoft Office products.
• Ability to be trained.
• Ability to interact well with employees at all levels.
• Ability to negotiate.
• Ability to interface with clients.