FLQA 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, 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.

Reporting to the Sr. Manager of Process FLQA, you will work onsite at our Holly Springs, NC Facility. You will apply quality principles related to equipment qualification, technical transfer, process, cleaning, method, and computer system validation and front line support for triage, deviation investigation approval, and change management. Primary areas of support will be Quality Control, Facilities Operations, and Warehousing. You will utilize integrated commissioning and qualification principles to ensure compliance. These principles will support the development and maintenance of quality procedures and systems related to Quality Assurance oversight. Additionally, you will provide technical support for the US FCC site in all cGMP compliance related matters. This includes assurance that all aspects comply with cGMPs, legal, and regulatory requirements.

Responsibilities:

• Ensure that qualification, validation, and technical protocols, and reports comply with site SOPs. Provide review and approval of related documents
• Provide QA oversight to equipment qualification, technical transfers, process, method, cleaning and computer system validation including revalidation and re-evaluation
• Maintain audit program, reviewing functional and release documentation, and reviewing and approving deviation investigations relevant to area(s) of responsibility
• Review lot release documentation and Facilitate compliant release process for corresponding market
• Respond to questions from authorities (Swissmedic, FDA, etc.) to ensure timely product release
• Ensure standard operating procedures (SOP's) stay current and align with corporate and regulatory requirements
• Interface with customers and partners on quality related issues
• Execute training/awareness related to GMP standards
• Provide training on quality concepts and tools

Qualifications:

• University degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry)
• 3+ years' GMP experience in pharmaceutical/biotech or other regulated industry
• Knowledge of current Good Manufacturing Practices (cGMP) principles
• Knowledge of FDA and EMA requirements

Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.

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