Responsibility:

• Conduct and review investigations of lab deviations and client exceeded concern levels.
• Possess the knowledge and ability to conduct and host client and regulatory audits professionally, ethically, and objectively.
• Assume the role of the CAPA coordinator. Responsible for overseeing the conduct of the CAPA and organizing meetings and updates as necessary.
• Assist the change control coordinator and will assume a role where needed.
• Maintain training records and documentation.
• Conduct review of internal methods and protocols.
• Review documentation such as raw data and reports, quality control records, quality assurance records, and reports for completeness, accuracy, and compliance with methods, protocols, guidelines, and regulations and FDA regulations
• Assure proper control of laboratory documentation.
• Responsible for the implementation, maintenance, and improvement of quality systems.
• Collaborate with managerial reports and trends.
• Provide guidance to peers regarding quality and regulatory issues.
• Problem-solve quality issues to preserve the original timeline for various projects; tracking progress while accountable for quality system deliverables.
• Accountable for overseeing the lab’s adherence to all relevant quality requirements.
• Analyze and identify opportunities to reduce process variation.
• Must have QA Engineering in a MFG environment.
• Must have QA engineering experience from a pharma company and must have a BS in a engineering discipline.
• Must have at least 10 years experience while working as a QA Engineer for a pharma company.