Specialist I, QA

QA Specialist (Day) Seqirus is seeking a QA Specialist to work onsite at the CSL Seqirus facility in Holly Springs, NC. The role reports to the QA Supervisor and focuses on direct quality oversight of manufacturing, laboratories, utilities, maintenance, and logistics on the production floor. Shift: Day Hours: 6AM–6PM Follow 2-2-3 schedule Job level will be determined based on years of relevant experience. 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. Act as a quality representative on the floor during manufacturing operations and troubleshooting; escalates potential product or process issues as needed. Provide quality oversight of site critical alarm reports and corrective maintenance program. Support development and revision of SOPs and batch records. Perform change control activities, including writing deviations and investigations, and use electronic enterprise systems such as Veeva, SAP, LIMS. Apply knowledge of regulatory requirements for pharmaceutical, biotech, and vaccine industries. Participate in external and internal audits and represent the Quality function. Experience and Qualifications Bachelor’s degree in a Science or Engineering discipline preferred, or equivalent experience in biotech or pharmaceutical industry. Experience in GMP fermentation, purification, sterile formulation, sterile filling, or packaging operations with technical knowledge of production processes used in the pharmaceutical or biotechnology industry. Experience in a quality role within an FDA‑regulated manufacturing or laboratory setting or understanding of the quality requirements for the pharmaceutical industry. Demonstrated risk‑based decision making. Experience leading complex projects or teams. Experience in root cause analysis, including use of tools such as fishbone/5Why. Benefits Onsite café. ½ mile walking trail, basketball and tennis courts. Medical, dental, vision, and life insurance. 401(k) with a 6% match. Annual bonus. Accrued PTO, wellness days, and floating holidays. Equal Opportunity Employer CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please let us know. #J-18808-Ljbffr CSL