Night QA Specialist: Pharma Manufacturing

CSL; Holly Springs (NC); On-site; USD 85,000 - 110,000; Full time

Benefits offered by this job

Onsite Café

Onsite Walking Trail

Sports courts (basketball/tennis)

Medical/Dental/Vision/Life Insurance

401K with 6% match

PTO, wellness days & floating holidays

Job summary

Seqirus in Holly Springs, NC seeks a QA Specialist (Night) to lead on-floor quality oversight in manufacturing, labs, and utilities. You will ensure cGMP compliance and support regulatory requirements while collaborating with cross-functional teams in a fast-paced vaccine production environment.

The role emphasizes real-time batch review, change controls, and rigorous quality systems, with opportunities for professional growth in a globally connected company.

Qualifications

• Bachelor’s degree in Science or Engineering preferred (or equivalent experience).
• Experience in GMP fermentation/purification/packaging with technical process knowledge.
• Experience in FDA-regulated manufacturing or laboratory quality role.

Responsibilities

• Perform real-time batch record/logbook reviews on the manufacturing floor.
• Conduct routine quality walkthroughs and audits in manufacturing and controlled spaces.
• Support QA-related quality systems for in-process sampling and controls.
• Be a quality floor representative during manufacturing; escalate issues as needed.
• Oversee site critical alarm reports and corrective maintenance programs.
• Assist in developing and revising SOPs and batch records.
• Engage in change controls, deviations, investigations; use Veeva, SAP, LIMS.
• Apply regulatory knowledge for pharmaceutical, biotech, and vaccine industries.
• Participate in internal and external audits and represent the Quality function.

Skills

QA on floor

Risk-based decision making

Root cause analysis

Team leadership

GMP knowledge

Education

Bachelor’s degree in Science/Engineering

Tools

Veeva

SAP

LIMS

Job description

Seqirus in Holly Springs, NC seeks a QA Specialist (Night) to lead on-floor quality oversight in manufacturing, labs, and utilities. You will ensure cGMP compliance and support regulatory requirements while collaborating with cross-functional teams in a fast-paced vaccine production environment.

The role emphasizes real-time batch review, change controls, and rigorous quality systems, with opportunities for professional growth in a globally connected company.