QA Specialist – Day Shift, Onsite GMP Quality

CSL; Holly Springs (NC); Sur place; USD 65 000 - 90 000; Plein temps

Avantages offerts par ce poste

Onsite Café

Walking Trail

Fitness courts

Medical, Dental, Vision

401K with 6% match

Annual bonus

PTO & wellness days

Floating holidays

Résumé du poste

Seqirus in Holly Springs, NC is seeking a QA Specialist (Day) to oversee on-the-floor quality for manufacturing, labs, and utilities. You’ll ensure cGMP compliance, support QA systems, and participate in audits and investigations.

Responsibilities include batch record review, quality walkthroughs, SOP updates, and collaboration with cross-functional teams to maintain product quality and regulatory readiness.

Qualifications

• Bachelor’s degree preferred or equivalent biotech/pharma experience.
• Experience in GMP fermentation, purification, sterile formulation, filling, or packaging operations.
• Experience in a FDA-regulated manufacturing or laboratory quality role.

Responsabilités

• 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 troubleshoot; 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.
• Participate in change controls, deviations and investigations, using electronic systems – Veeva, SAP, LIMS, etc.
• Apply knowledge of regulatory requirements for pharmaceutical, biotech and vaccine industries.
• Participate in external and internal audits and represent the Quality function.

Connaissances

Quality Assurance

GMP

Audit/Inspection

Root Cause Analysis

Leadership

Formation

Bachelor’s degree in Science/Engineering

Outils

Veeva

SAP

LIMS

Description du poste

Seqirus in Holly Springs, NC is seeking a QA Specialist (Day) to oversee on-the-floor quality for manufacturing, labs, and utilities. You’ll ensure cGMP compliance, support QA systems, and participate in audits and investigations.

Responsibilities include batch record review, quality walkthroughs, SOP updates, and collaboration with cross-functional teams to maintain product quality and regulatory readiness.