Senior Quality System Specialist

Responsibilities:

• Support the design, review, and documentation of deviations, change controls, and CAPAs, including impact and risk assessments.
• Provide troubleshooting support for electronic Quality Management Systems (eQMS).
• Assist in the continuous improvement of Deviation Management, Change Management, and CAPA programs.
• Maintain and analyze Quality Systems metrics to identify trends, process improvements, and risk mitigation opportunities.
• Support internal and external audit activities, including interactions with auditors and regulatory inspectors.
• Participate in investigation planning, assessment activities, and Quality Event decision-making processes.
• Author, review, and revise controlled documents including SOPs, work instructions, and forms in compliance with GMP requirements.
• Assist with Annual Product Reviews (APR) and Product Quality Reviews (PQR), including trending and data analysis activities.
• Promote and support data integrity principles (ALCOA+) across quality systems and documentation practices.

Qualifications:

• Bachelor’s degree in a scientific discipline or related field.
• Minimum 5 years of experience in a regulated industry environment.
• Minimum 3 years of experience supporting Quality Systems processes.
• Experience supporting deviations, change controls, investigations, and CAPA activities.
• Working knowledge of FDA regulations (21 CFR Parts 210/211) and ICH guidelines (Q9/Q10).
• Understanding of GMP data integrity principles (ALCOA+) and electronic documentation systems.