Specialist I, II, III Manufacturing Quality Systems

Seqirus•Holly Springs, NC

3d•Onsite

About The Position

The Manufacturing Quality Systems Specialist supports Fill Finish manufacturing operations by leading investigations, ensuring quality system execution, and providing technical expertise across multiple unit operations. You will maintain compliance within a cGMP environment while driving continuous improvement through root cause analysis to ensure corrective and preventative actions, documentation practices, and collaboration.

Requirements

Bachelor's degree in a Science or Engineering discipline, or equivalent industry experience.
Minimum of 1 year of experience in deviation management, root cause analysis, CAPA execution, and change control, preferably within the pharmaceutical or biotech industry.
Demonstrated experience working in a cGMP environment.
Troubleshooting skills with the ability to navigate complex technical issues.
Organizational, planning, and time‑management skills.

Responsibilities

Manage deviations, including authorship of comprehensive product impact assessments.
Lead cross‑functional investigation teams to perform root cause analysis and identify sustainable corrective actions.
Develop, implement, and monitor CAPA plans aimed at preventing recurrence of quality events.
Perform Product Technical Complaint and Adverse Event investigations, ensuring timely and compliant resolution.
Author Biological Product Deviation Reports (BPDRs) for submission to the FDA, ensuring accuracy and regulatory compliance.
Oversee change controls, including complex and site‑wide change control activities.
Develop and deliver technical training materials to support manufacturing processes and employee development.