You will be responsible for direct, on the floor, quality oversight of Seqirus Holly Springs' manufacturing, laboratories, utilities, maintenance, and logistics
Job Summary
You 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
You will be responsible for direct, on the floor, quality oversight of Seqirus Holly Springs' manufacturing, laboratories, utilities, maintenance, and logistics.
Skills & Requirements
Must-have
cGMP compliance
Quality oversight
Batch record review
SOP development
Deviation investigations
Regulatory requirements
Nice-to-have
Risk-based decision making
Team collaboration
Problem-solving
Making a difference
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