Front Line Qa Specialist (days)

CSL Seqirus

Holly Springs, NC, United States
On-site
Cgmp compliance
On the floor quality oversight
Real-time batch record review
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

  • cGMP compliance
  • on the floor quality oversight
  • real-time batch record review
  • SOP and batch record support
  • electronic enterprise systems

Nice-to-have

  • making a difference in people's lives
  • feeling of possibility, creativity, and purpose
  • collaborative global company

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
  • Risk-based decision making
  • Root cause analysis experience

Work Rights

Not specified

Tailored Resume

Cover Letter