Specialist I /II / III, QA

CSL; Holly Springs (NC); Presencial; USD 85 000 - 110 000; Tempo integral

Vantagens oferecidas por esta oferta de emprego

Onsite Café

Onsite Walking Trail

Sports courts (basketball/tennis)

Medical/Dental/Vision/Life Insurance

401K with 6% match

PTO, wellness days & floating holidays

Resumo da oferta

Seqirus in Holly Springs, NC seeks a QA Specialist (Night) to lead on-floor quality oversight in manufacturing, labs, and utilities. You will ensure cGMP compliance and support regulatory requirements while collaborating with cross-functional teams in a fast-paced vaccine production environment.

The role emphasizes real-time batch review, change controls, and rigorous quality systems, with opportunities for professional growth in a globally connected company.

Qualificações

• Bachelor’s degree in Science or Engineering preferred (or equivalent experience).
• Experience in GMP fermentation/purification/packaging with technical process knowledge.
• Experience in FDA-regulated manufacturing or laboratory quality role.

Responsabilidades

• Perform real-time batch record/logbook reviews on the manufacturing floor.
• Conduct routine quality walkthroughs and audits in manufacturing and controlled spaces.
• Support QA-related quality systems for in-process sampling and controls.
• Be a quality floor representative during manufacturing; escalate issues as needed.
• Oversee site critical alarm reports and corrective maintenance programs.
• Assist in developing and revising SOPs and batch records.
• Engage in change controls, deviations, investigations; use Veeva, SAP, LIMS.
• Apply regulatory knowledge for pharmaceutical, biotech, and vaccine industries.
• Participate in internal and external audits and represent the Quality function.

Conhecimentos

QA on floor

Risk-based decision making

Root cause analysis

Team leadership

GMP knowledge

Formação académica

Bachelor’s degree in Science/Engineering

Ferramentas

Veeva

SAP

LIMS

Descrição da oferta de emprego

QA Specialist (Night)

Do you want to work with a company that tackles fascinating problems and find solutions to complex challenges? Seqirus has an exciting opportunity to join our expanding team in Holly Springs, NC. With an advanced manufacturing facility and expertise in influenza science we are one of the world leaders in the production of the influenza vaccine. We operate as one integrated global company, drawing together expert staff from different countries to collaborate. Together, we're working on the front line to protect communities from seasonal influenza and global pandemic threats. When you join Seqirus, you join a team dedicated to making a difference in people's lives. It's a feeling of possibility, creativity, and purpose that inspires us every day.

The QA Specialist will be reporting to the QA Supervisor. You will work onsite at our CSL Seqirus in Holly Springs, NC location. You will be responsible for direct, on the floor, quality oversight of Seqirus Holly Springs' manufacturing, laboratories, utilities, maintenance, and logistics. You will provide strategic and technical support for the site's cGMP compliance related matters, including assurance that all aspects comply with cGMPs, legal, regulatory requirements, and the Seqirus Quality Manual requirements. Our benefits include an Onsite Café, 1/2 mile Walking Trail, Basketball and Tennis Courts; access to Medical, Dental, Vision, Life Insurance, 401K with a 6% match and an annual bonus; and accrued PTO, wellness days and floating holidays.

• Shift: Nigh
• Hours: 6PM - 6AM
• Follow 2-2-3 schedule
• Job level will be determined based on years of relevant experience to our processes and equipment

Responsibilities

• Perform real-time batch record/logbook review concurrent with manufacturing operations on the manufacturing 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 the development and revision of SOPs and batch records
• Perform activities related to change controls, writing deviations and investigations, and using electronic enterprise 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

Experience

• Bachelor’s degree in Science/ Engineering discipline preferred or equivalent experience in biotech or pharmaceutical industry
• Experience in a GMP fermentation, purification, sterile formulation, sterile filling, or packaging operation with technical knowledge of the production processes used in the pharmaceutical or biotechnology industry
• Experience in quality role in an FDA regulated manufacturing or laboratory setting or an understanding of the quality requirements for the pharmaceutical industry
• Demonstrate risk-based decision making
• Experience leading complex projects or teams
• Experience in root cause analysis, including working experience of root cause analysis tools such as fishbone/5Why