Quality Assurance Specialist

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 were 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 peoples lives. Its 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 sites 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 Caf 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: Day
• Hours: 6 AM 6PM
• 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

• Bachelors 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

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Our Benefits

CSL Seqirus employees that work at least 30 hours per week are eligible for benefits effective day 1. We are committed to the wellbeing of our employees and their loved ones. CSL Seqirus offers resources and benefits from health care to financial protection so you can focus on doing work that matters. Our benefits are designed to support the needs of our employees at every stage of their life. Whether you are considering starting a family need help paying for emergency back up care or summer camp looking for mental health resources planning for your financial future or supporting your favorite charity with a matching contribution CSL Seqirus has many benefits to help achieve your goals.

Please take the time to review our benefits site to see whats available to you as a CSL Seqirus employee.

About CSL Seqirus

CSL Seqirus is part of CSL Limited (ASX: CSL). As one of the largest influenza vaccine providers in the world CSL Seqirus is a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. Learn more about CSL Seqirus.

We want CSL Seqirus to reflect the world around us

As a global organization with employees in 35 countries CSL embraces inclusion and belonging. Learn more about Inclusion & Belonging at CSL.

Do work that matters at CSL Seqirus!

Watch our On the Front Line video to learn more about CSL Seqirus