Specialist I, II, III Manufacturing Quality Systems

The Manufacturing Quality Systems Specialist supports Fill Finish manufacturing operations by leading investigations, ensuring quality system execution, and providing technical expertise across multiple unit operations. You will maintain compliance within a cGMP environment while driving continuous improvement through root cause analysis to ensure corrective and preventative actions, documentation practices, and collaboration.

Responsibilities

• Manage deviations, including authorship of comprehensive product impact assessments.
• Lead cross‑functional investigation teams to perform root cause analysis and identify sustainable corrective actions.
• Develop, implement, and monitor CAPA plans aimed at preventing recurrence of quality events.
• Perform Product Technical Complaint and Adverse Event investigations, ensuring timely and compliant resolution.
• Author Biological Product Deviation Reports (BPDRs) for submission to the FDA, ensuring accuracy and regulatory compliance.
• Oversee change controls, including complex and site‑wide change control activities.
• Develop and deliver technical training materials to support manufacturing processes and employee development.

Minimum Qualifications

• Bachelor's degree in a Science or Engineering discipline, or equivalent industry experience.
• Minimum of 1 year of experience in deviation management, root cause analysis, CAPA execution, and change control, preferably within the pharmaceutical or biotech industry.
• Demonstrated experience working in a cGMP environment.
• Troubleshooting skills with the ability to navigate complex technical issues.
• Organizational, planning, and time‑management skills.

About CSL Seqirus

CSL Seqirus is part of 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. With state-of-the-art production facilities in the U.S., the U.K. and Australia, CSL Seqirus utilizes egg, cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.

Our Benefits

For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.

You Belong at CSL

At CSL, Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy, we are able to better understand and connect with our patients and donors, foster strong relationships with our stakeholders, and sustain a diverse workforce that will move our company and industry into the future.

 To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging

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 visit https://www.csl.com/accessibility-statement.

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