Manufacturing Quality Systems Specialist - Fill Finish
Seqirus
Holly Springs, NC, US
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Cgmp environment
Deviation management
Root cause analysis
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Seqirus is seeking a Manufacturing Quality Systems Specialist for their Fill Finish operations in Holly Springs, NC. The role requires expertise in deviation management, root cause analysis, and compliance in a cGMP environment, contributing to the production of influenza vaccines.
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Job Summary
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.
Responsibilities include managing deviations, leading cross-functional investigation teams, developing and monitoring CAPA plans, performing product complaint investigations, writing and revising SOPs, authoring Biological Product Deviation Reports, overseeing change controls, and providing technical support.
Benefits include Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.
Matching Summary
Match Score: 75
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Seqirus is seeking a Manufacturing Quality Systems Specialist for their Fill Finish operations in Holly Springs, NC. The role requires expertise in deviation management, root cause analysis, and compliance in a cGMP environment, contributing to the production of influenza vaccines.
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Skills & Requirements
Must-have
cGMP environment
deviation management
root cause analysis
CAPA execution
change control
technical expertise
Nice-to-have
continuous improvement
collaboration
employee development
inclusion and belonging
Key Requirements
Bachelor's degree in Science or Engineering or equivalent industry experience
Minimum 1 year experience in deviation management, root cause analysis, CAPA execution, and change control
Demonstrated experience in a cGMP environment
Troubleshooting skills
Organizational, planning, and time-management skills