Night QA Specialist - On-Floor GMP & Compliance

CSL; Holly Springs (NC); Hybrid; USD 85,000 - 105,000; Full time

Benefits offered by this job

Onsite Café

Walking Trail

Basketball and Tennis Courts

Medical, Dental, Vision

401K with 6% match

Annual bonus

Job summary

Seqirus in Holly Springs, NC is seeking a QA Specialist (Night) to oversee quality on the manufacturing floor, labs, utilities, and logistics. You’ll ensure cGMP compliance, support regulatory requirements, and collaborate with cross-functional teams in a fast-paced vaccine production setting.

The role reports to the QA Supervisor and requires real-time batch oversight, investigations, and change control activities.

Qualifications

• Bachelor’s degree in Science/Engineering preferred or equivalent biotech/pharma experience
• GMP manufacturing/packaging experience
• Experience in FDA-regulated manufacturing or a laboratory setting
• Demonstrate risk-based decision making
• Experience leading complex projects or teams
• Experience in root cause analysis using fishbone/5Why

Responsibilities

• Perform real-time batch record/logbook review concurrent with manufacturing operations on the floor
• Perform routine quality walkthroughs and audits in manufacturing and controlled spaces
• Support quality systems related to QA for in-process sampling and controls
• Be a quality representative on the floor during manufacturing operations and troubleshooting; escalate issues as needed
• Provide quality oversight of site critical alarm reports and corrective maintenance program
• Support the development and revision of SOPs and batch records
• Perform activities related to change controls, deviations and investigations, using Veeva, SAP, LIMS
• Apply knowledge of regulatory requirements for pharmaceutical/biotech/vaccine industries
• Participate in external and internal audits and represent the Quality function

Skills

GMP knowledge

Risk-based decision making

Root cause analysis

Project leadership

Quality audits

On-floor QA oversight

Education

Bachelor’s degree in Science/Engineering

Tools

Veeva

SAP

LIMS

Job description

Seqirus in Holly Springs, NC is seeking a QA Specialist (Night) to oversee quality on the manufacturing floor, labs, utilities, and logistics. You’ll ensure cGMP compliance, support regulatory requirements, and collaborate with cross-functional teams in a fast-paced vaccine production setting.

The role reports to the QA Supervisor and requires real-time batch oversight, investigations, and change control activities.