The QA Specialist will be responsible for direct, on the floor, quality oversight of Seqirus Holly Springs' manufacturing, laboratories, utilities, maintenance, and logistics
Job Summary
The QA Specialist will be responsible for direct, on the floor, quality oversight of Seqirus Holly Springs' manufacturing, laboratories, utilities, maintenance, and logistics.
You will provide strategic and technical support for the site's cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the Seqirus Quality Manual requirements.
Our benefits include an Onsite Café, 1/2 mile Walking Trail, Basketball and Tennis Courts; access to Medical, Dental, Vision, Life Insurance, 401K with a 6% match and an annual bonus; and accrued PTO, wellness days and floating holidays.
Matching Summary
The QA Specialist will be responsible for direct, on the floor, quality oversight of Seqirus Holly Springs' manufacturing, laboratories, utilities, maintenance, and logistics.
Skills & Requirements
Must-have
On the floor quality oversight
cGMP compliance support
Real-time batch record review
Quality systems support
SOP and batch record development
Change control and deviation management
Nice-to-have
Risk-based decision making
Collaborative global company
Making a difference in people's lives
Feeling of possibility and purpose
Key Requirements
Bachelor's degree in Science/Engineering or equivalent experience
Experience in GMP fermentation, purification, sterile formulation, sterile filling, or packaging
Experience in quality role in FDA regulated setting