QA Specialist

About the role

The Quality Assurance Specialist is responsible for implementing and overseeing the Quality Documentation System Program to enhance operational efficiency and ensure compliance with regulatory and internal quality standards. This role plays a key part in maintaining robust quality systems, supporting audits and inspections, and driving continuous improvement across processes and operations.

Responsibilities

• Implement and oversee the company's Quality Documentation System Program to ensure it is effective, compliant, and aligned with operational needs.
• Conduct internal quality audits to assess compliance with procedures, GMP, and regulatory requirements, and follow up on findings.
• Deliver personnel training on quality processes, documentation practices, and regulatory expectations, and provide direct feedback on quality status to staff and management at all levels.
• Identify process and operational improvements that enhance quality, efficiency, and consistency across departments.
• Identify critical control points within processes and implement appropriate quality procedures to manage and mitigate risks.
• Create, implement, and maintain departmental standard operating procedures (SOPs) and forms to support consistent and compliant operations.
• Review batch records and other quality-related records and documents to ensure accuracy and compliance with internal procedures, GMP, FDA, and other regulatory requirements.
• Perform trending analysis on quality data to identify patterns, recurring issues, and opportunities for corrective and preventive actions.
• Provide support during inspections and audits conducted by internal teams and external regulatory authorities.
• Manage nonconformance reports (NCR) and corrective actions processes, ensuring issues are documented, investigated, and resolved effectively.
• Oversee QA/QC document control activities, including the management, revision, and archival of controlled documents.
• Serve as a liaison with national and international regulatory authorities, facilitating communication and documentation as needed.
• Perform additional quality-related duties as assigned by supervisory or management personnel.

Requirements

• Demonstrated experience in quality assurance and quality control within a regulated environment.
• Hands-on experience with batch record review, including verifying completeness, accuracy, and compliance with GMP and FDA requirements.
• Strong knowledge of FDA regulations, GMP, and other relevant regulatory frameworks.
• Proficiency in QA/QC document control, including creation, revision, and management of SOPs and controlled documents.
• Ability to implement and manage a Quality Documentation System Program effectively.
• Experience conducting internal audits and supporting external inspections and audits.
• Skill in identifying critical control points and establishing appropriate quality procedures.
• Ability to perform trending analysis on quality data and translate findings into actionable improvements.
• Strong communication skills, with the ability to provide clear feedback on quality status to staff and management.
• Excellent organizational skills and attention to detail when reviewing records and documentation.
• Education in biology or a related scientific field.
• Experience working with national and international regulatory authorities.
• Proven ability to identify process and operational improvements and drive continuous improvement initiatives.
• Comfort working in a collaborative team environment with dynamic, communic