Specialist I /II / III, QA

Seqirus • Holly Springs, NC

1d • Onsite

About The Position

The QA Specialist provides direct, on-the-floor quality oversight of manufacturing, laboratories, utilities, maintenance, and logistics at Seqirus’s Holly Springs, North Carolina site. Reporting to the QA Supervisor, the role provides strategic and technical support for site cGMP compliance and helps ensure operations meet cGMP, legal, regulatory, and Seqirus Quality Manual requirements. The position is onsite and works a night schedule from 6 p.m. to 6 a.m. on a 2-2-3 rotation. Job level (I, II, or III) is determined by relevant experience with the site’s processes and equipment.

Requirements

• Experience in a GMP fermentation, purification, sterile formulation, sterile filling, or packaging operation, with technical knowledge of pharmaceutical or biotechnology production processes.
• Experience in a quality role in an FDA-regulated manufacturing or laboratory setting, or understanding of pharmaceutical-industry quality requirements.
• Demonstrated risk-based decision-making.
• Experience leading complex projects or teams.
• Experience in root cause analysis, including practical use of tools such as fishbone and 5 Why.
• Relevant experience with the site's processes and equipment; job level is determined based on this experience.

Nice To Haves

• Bachelor’s degree in a science or engineering discipline, or equivalent experience in the biotech or pharmaceutical industry.

Responsibilities

• Perform real-time batch record and logbook reviews concurrent with manufacturing operations on the manufacturing floor.
• Conduct routine quality walkthroughs and audits in manufacturing and controlled spaces.
• Support QA quality systems related to in-process sampling and controls.
• Represent Quality 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 the corrective maintenance program.
• Support development and revision of SOPs and batch records.
• Perform change control activities, write deviations and investigations, and use electronic enterprise systems including Veeva, SAP, and LIMS.
• Apply regulatory requirements for the pharmaceutical, biotech, and vaccine industries.
• Participate in external and internal audits and represent the Quality function.

Benefits

• Onsite café, walking trail, basketball courts, and tennis courts.
• Medical, dental, vision, and life insurance.
• 401(k) with a 6% match.
• Annual bonus.
• Accrued PTO, wellness days, and floating holidays.

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level