Specialist, Quality Assurance

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 Front Line Quality Assurance (FLQA) Specialist will provide strategic, technical and quality support to ensure all aspects of operations comply with cGMPs, legal, regulatory, and the CSL Seqirus Quality Manual requirements. You will be reporting to the Sr. Manager, QA. You will work onsite at our CSL Seqirus in Holly Springs, NC location Monday-Friday during primary business hours. You may be considered at level II or III depending on experience. The Role Function as primary FLQA and Quality Management System (QMS) subject matter expert to assigned area(s) of responsibility within Bulk Manufacturing, QC laboratories, Fill Finish Manufacturing, Facilities, and Warehouse operations. Perform quality oversight and approval of Deviations, CAPAs, and Change Controls in collaboration with Record Owners. Ensure investigations, cause identification, CAPA development, and accurate change controls within Bulk, QC, Fill Finish, FacOps, and Warehouse departments. Track closure of assigned QMS records. Participate in suite team meetings, provide FLQA support for projects and initiatives. Conduct on-the-floor walkthroughs and coaching to instill a quality mindset, compliance knowledge, and a strong quality culture among manufacturing staff. Bring adherence to and continuous improvement of quality systems within Bulk, QC, Fill Finish, FacOps, and Warehouse departments. Support development, revision, and implementation of SOPs, protocols, and other GMP documents.• Help deliver Deviation, CAPA, and Change Control Annual Product Quality Review (APQR) sub-reports. Lead continuous improvement projects, offer quality support to site capital projects and global quality system improvements. Ensure inspection readiness through routine quality walkthroughs, monitoring adherence, and direct involvement in Site Self Inspections. Be a QA SME for internal and external audits. Proficiently use computerized systems including TrackWise, Veeva QMS and QDocs, GLIMS, SAP, CMMS. Provide support to greater FLQA organization, including quality oversight of Bulk Manufacturing/QC Laboratories and QA reviews of batch records and GMP records at the site. Acquire and maintain knowledge of current local and international regulatory requirements/trends, ensuring advice and technical support on quality/compliance matters are provided to the site. Your Experience: Bachelor's degree in a relevant scientific discipline (Pharmacy, Chemistry, Biology, Biochemistry) preferred or equivalent experience in biotech or pharmaceutical industry 3 years' GMP experience in the pharmaceutical/biotech industry Previous experience directly working in the industry or having direct responsibilities approving GMP deviations, CAPAs, and change controls. Previous experience in root cause analysis and risk management, including working experience of root cause analysis tools such as Fishbone/5Why Previous experience in quality role in an FDA regulated manufacturing or laboratory setting or an understanding of the quality requirements for the pharmaceutical industry. Experience with the production processes used in pharmaceutical parenteral drug product manufacturing Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable. Benefits: Onsite Café, Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire. 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 what’s 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 diversity and inclusion. Learn more about Diversity & Inclusion at CSL Seqirus. Do work that matters at CSL Seqirus! Watch our ‘On the Front Line’ video to learn more about CSL Seqirus CSL Seqirus 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 click here.

Salary : $67,000 - $84,800