Manufacturing Quality Systems Specialist - Fill Finish
Seqirus
Holly Springs, NC, US
Not specified (assumed to be onsite based on the nature of the role).
Deviation management
Root cause analysis
Capa execution
Seqirus is seeking a Manufacturing Quality Systems Specialist to support Fill Finish manufacturing operations in Holly Springs, NC. The role involves leading investigations, ensuring compliance in a cGMP environment, and driving continuous improvement within the manufacturing process
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, performing root cause analysis, and authoring Biological Product Deviation Reports (BPDRs).
Benefits include Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.
Matching Summary
Match Score: 85
Seqirus is seeking a Manufacturing Quality Systems Specialist to support Fill Finish manufacturing operations in Holly Springs, NC. The role involves leading investigations, ensuring compliance in a cGMP environment, and driving continuous improvement within the manufacturing process.
Skills & Requirements
Must-have
Deviation management
Root cause analysis
CAPA execution
cGMP environment
Technical troubleshooting
SOP and batch record revision
Nice-to-have
Continuous improvement
Cross-functional team leadership
Employee development training
Collaboration and empathy
Key Requirements
Bachelor's degree in Science or Engineering or equivalent experience
Minimum 1 year experience in deviation management, RCA, CAPA, change control
Experience in pharmaceutical or biotech industry
Demonstrated cGMP environment experience
Troubleshooting skills
Organizational, planning, and time-management skills