Audit Support Specialist

Job Responsibilities:

• Plan and coordinate internal audits, client audits, and regulatory inspections.
• Serve as the primary point of contact during audits, ensuring timely communication and preparedness.
• Organize and maintain audit schedules, agendas, and documentation.
• Support audit hosts and subject matter experts during audits by facilitating meetings, presentations, and documentation reviews.
• Prepare, review, and organize audit-related documents, ensuring accuracy and compliance with current Good Manufacturing Practices (cGMP).
• Ensure timely retrieval and submission of requested documents to auditors or inspectors.
• Maintain accurate records of audit findings, corrective actions, and follow-up activities.
• Monitor industry regulations and standards (e.g., FDA, EMA, ICH) to ensure audit processes remain compliant.
• Support teams in implementing corrective and preventive actions (CAPAs) identified during audits.
• Assist in reviewing quality documentation to ensure compliance with customer and regulatory requirements.
• Analyze audit outcomes to identify trends and areas for improvement.
• Collaborate with cross-functional teams to develop and implement quality improvement initiatives.
• Provide training and guidance to staff on audit readiness and compliance practices.

Qualifications:

• Bachelor’s degree in life sciences, chemistry, engineering, or a related field.
• 3+ years of experience in quality assurance, audit coordination, or compliance in a biopharma or CDMO environment.
• Familiarity with cGMP, ISO standards, and global regulatory requirements (e.g., FDA, EMA, MHRA).
• Proficiency in documentation systems and electronic quality management systems.