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. The Front Line Quality Assurance (FLQA) Specialist will provide strategic, technical and quality support for manufacturing, laboratories, warehouse and utility operations at the Holly Springs site to ensure all aspects of operations comply with cGMPs, legal, regulatory, and the CSL 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.
This position is for a FLQA Specialist role working Monday-Friday during core business hours. You must be flexible in their schedule and work assignments to support the business and the seasonal needs of influenza vaccine production.
Responsibilities
- Function as primary FLQA and Quality Management System (QMS) subject matter expert to assigned area(s) of responsibility
- Perform the quality oversight and approval of Deviations, CAPAs, and Change Controls in close collaboration with Record Owners throughout the process. Ensures the robust investigation, identification of root cause, the development and execution of strong and robust CAPAs, and the technical accuracy and comprehensive scope of change controls within assigned area(s) of oversight
- Monitor and track on-time closure of assigned QMS records.
- Participate in cross-functional suite team meetings and provide FLQA support of suite team projects and initiatives
- Provide on-the-floor walkthroughs and coaching to manufacturing staff to embed a quality mindset, build compliance knowledge and sustain a strong quality culture
- Drive adherence to and continuous improvement of the quality systems within assigned area(s) of responsibility
- Support the development, revision and implementation of SOPs, protocols, and other GMP documents.
- Assists in the delivery of the Deviation, CAPA, and Change Control Annual Product Quality Review (APQR) sub-reports
- Lead continuous improvement projects and may provide quality support to site capital projects and/or global quality system improvement projects
- Ensure inspection readiness in assigned area of support via performing routine quality walkthroughs, monitoring quality system adherence, and direct involvement in Site Self Inspections
- Function as the QA SME for internal and external audits
- Must be proficient in the use of computerized systems including but not limited to: TrackWise, Veeva QMS and QDocs, GLIMS, SAP, CMMS
- As needed, supports greater FLQA organization including shop floor quality oversight and QA reviews of batch records and other GMP records at the site.
- Acquires and maintains knowledge of current local and international regulatory requirements/trends to ensure that expert advice and appropriate technical support on all quality/compliance related matters are provided to the site.
Requirements
- Bachelors 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 vaccine manufacturing operations and/or QC laboratories and/or previous experience in ownership and/or approval of 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 ownership and/or approval of GMP deviations, CAPAs, and change controls
- Previous experience in quality role in an FDA regulated manufacturing or laboratory setting or a strong understanding of the quality requirements for the pharmaceutical industry.
- Strong technical understanding of the production processes used in pharmaceutical parenteral drug product manufacturing
- Demonstrated knowledge of cGMPs, FDA requirements, and Quality Systems
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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 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
What We Do
CSL is a leading global biotechnology company with a dynamic portfolio of lifesaving medicines, including those that treat haemophilia and immune deficiencies, vaccines to prevent influenza, and therapies in iron deficiency, dialysis and nephrology. Since our start in 1916, we have been driven by our promise to save lives using the latest technologies.
Today, CSL – including our businesses, CSL Behring, CSL Seqirus, CSL Plasma and CSL Vifor – provides lifesaving products to patients in more than 100 countries and employs 32,000 people. Our unique combination of commercial strength, R&D focus and operational excellence enables us to identify, develop and deliver innovations so our patients can live life to the fullest.
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