Manufacturing Quality Systems Specialist - #250898

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 the state-of-the-art manufacturing facility and an 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 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 Manager, Manufacturing Quality Systems, you will work onsite in the Holly Springs office. You will be responsible for providing quality system support to Fill Finish manufacturing areas within the Seqirus Vaccines manufacturing facility located in Holly Springs, NC. Benefits Include Onsite Café, Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day.

Responsibilities

• Owns deviations and writes product impact assessments.
• Leads cross functional investigation teams in root cause analysis
• Creates and executes CAPA plans to reduce the likelihood of reoccurrence.
• Writes SOPs and batch records to support operation activities
• Owns change controls including site wide change controls.
• Writes Biological Product Deviation Report for submission to the FDA.
• Performs Product Technical Compliant and Adverse Event investigations.
• Provides technical support with multiple unit operations. Identifies solutions to address technical problems.
• Writes technical training material for manufacturing processes.
  
  
  

Minimum Qualifications

• Bachelor’s degree in Science or Engineering or equivalent industry experience required.
• Minimum of 1 years of experience with deviation investigations, root cause analysis, CAPA management , and Change Controls or equivalent experience in the pharmaceutical industry.
• Direct experience within a cGMP environment
• Demonstrated troubleshooting skills
• Strong organizational, planning and time management skills
• Strong oral, written and interpersonal communication skills
  
  
  

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

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!

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