Night QA Specialist — GMP & Manufacturing Oversight

CSL Plasma; Holly Springs (NC); On-site; USD 65,000 - 90,000; Full time

Benefits offered by this job

Onsite Café

Medical, Dental, Vision, Life

401K with 6% match

Annual bonus

PTO and floating holidays

Job summary

Seqirus in Holly Springs, NC is seeking a QA Specialist for Night shift to oversee manufacturing, labs, utilities, maintenance, and logistics on the floor. You will ensure cGMP compliance across processes and documentation under the QA Supervisor.

The role requires real-time batch review, quality walkthroughs, and active involvement in change controls and problem resolution. Onsite work with potential for audits and cross-functional collaboration.

Qualifications

• Bachelor's degree in Science/Engineering or equivalent experience in biotech/pharma.
• Experience in a GMP fermentation, purification, sterile formulation, or packaging operation in pharma/biotech.
• Experience in FDA-regulated manufacturing or lab quality role.

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 potential product or process related issues as needed.
• Provide quality oversight of site critical alarm reports and corrective maintenance program.
• Support development and revision of SOPs and batch records.
• Participate in change controls, deviations, investigations, and use of electronic systems (Veeva, SAP, LIMS).
• Apply knowledge of regulatory requirements for pharmaceutical/biotech industries.
• Participate in external and internal audits and represent the Quality function

Skills

Batch record review

GMP knowledge

Risk-based decision making

Root cause analysis

On-site manufacturing

Education

Bachelor's degree in Science/Engineering

Tools

Veeva

SAP

LIMS

Job description

Seqirus in Holly Springs, NC is seeking a QA Specialist for Night shift to oversee manufacturing, labs, utilities, maintenance, and logistics on the floor. You will ensure cGMP compliance across processes and documentation under the QA Supervisor.

The role requires real-time batch review, quality walkthroughs, and active involvement in change controls and problem resolution. Onsite work with potential for audits and cross-functional collaboration.