Sr.Staff Quality Specialist

Sr.Staff Quality Specialist

Requirements

• Bachelor’s degree in a relevant field (e.g., Quality Management, Regulatory Affairs, Life Sciences)
• Minimum 11 years of experience in quality management with a focus on CAPA, audits, and regulatory compliance
• Strong knowledge of quality management principles, methodologies, and relevant regulations (e.g., FDA, ISO, GMP)
• Proficiency in CAPA software and auditing tools (e.g., TrackWise)
• Excellent analytical, problem-solving, and communication skills

Responsibilities

• Oversee the transition of audit findings from OneAudit system to the Corrective and Preventive Action (CAPA) in TrackWise
• Collaborate with cross-functional stakeholders to ensure proper, timely, and accurate transitions
• Maintain frequent communication on pertinent details of transitions with appropriate contacts
• Manage internal audit observations
• Collaborate with cross-functional teams to ensure adherence to regulatory requirements and internal policies
• Identify appropriate owners for audit findings and monitor audit phase timeliness
• Serve as a liaison between owners and internal auditors
• Identify areas of non-compliance and work with relevant departments to develop corrective action plans
• Perform administrative tasks within the audit system, where appropriate
• Stay up to date with relevant industry regulations and standards
• Ensure audit responses are complying and lead efforts to adapt to regulatory changes
• Prepare compliance reports for senior management
• Lead and participate in continuous improvement initiatives related to monitoring the audit program and overseeing audit phase execution

Preferred Qualifications

• Certification in Quality Management (e.g., Certified Quality Auditor, Certified Lean Six Sigma) is a significant advantage
• Exceptional attention to detail and a commitment to data accuracy
• Strong organizational and time management skills
• Ability to lead and collaborate effectively in a cross-functional team environment
• Analytical mindset with a passion for deriving insights from data
• Demonstrated integrity in handling sensitive data and adherence to ethical standards