Quality Systems Specialist

Overview

• Contribute to maintaining and enhancing quality systems in a hybrid work environment.
• Collaborate with cross-functional teams to ensure compliance with cGMPs and health authority guidelines.
• Develop, revise, and improve regional quality system SOPs and procedures.
• Perform inspection readiness activities and support quality outcomes.
• Analyze and report on quality metrics and risk assessments.
• Assist in resolving quality system issues and escalate as necessary.
• Support project management initiatives within the quality systems domain.
• Work collaboratively to ensure effective communication and understanding across teams.

Key Responsibilities & Duties

• Revise and improve quality system procedures and SOPs to meet compliance standards.
• Conduct analysis and reporting of quality metrics and risk factors.
• Monitor quality systems for gaps and escalate issues for resolution.
• Assist in inspection readiness activities and ensure adherence to cGMPs.
• Support cross-functional communication to drive quality outcomes.
• Manage projects within the quality systems area and coordinate with teams.
• Provide expertise in document control processes and electronic quality systems.
• Contribute to training operations and learning management systems.

Job Requirements

• Bachelor’s degree in chemistry, biochemistry, or related technical discipline.
• 3-5 years of experience in quality systems, auditing, and regulatory inspections.
• Proficiency in compliance with cGMPs and health authority guidelines.
• Experience in SOP writing, metrics monitoring, and issue resolution.
• Strong communication skills for effective collaboration across teams.
• Ability to escalate issues and seek timely support.
• Knowledge of electronic quality systems and document control processes.
• Proven performance in previous roles within the quality domain.