QA Specialist, Engineering - CSL

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 Quality Assurance Specialist will provide strategic support onsite at the Holly Springs, NC site to ensure all aspects of operations comply with cGMPs, legal, regulatory, and the CSL Seqirus Quality Manual requirements. You will report to the Senior Manager of QA Engineering. Benefits Include an annual bonus, Onsite Café, walking trail and other outdoor amenities, Medical, Dental, Vision, Life Insurance, 401K with a 6% match, and PTO available from your first day of hire.

Responsibilities:

• Provide validation documentation lifecycle oversight, including equipment qualification, process validation, method validation, and technology transfers.
• The QA-Engineering Specialist II/III will have QA oversight on validation deliverables in QC, Bulk Manufacturing, and Fill Finish collaborating with CQV (Commissioning Qualification and Validation), MS&T (Manufacturing Science and Technology), AS&T (Analytical Science and Technology), QC (Quality Control), Manufacturing, and Engineering.
• Communicate with customers and partners on quality related issues, participate as the QA representative on multi-functional continuous improvement teams, and ensure efficient project support.
• Use data analysis skills and statistical tools to interpret results to support acceptance criteria and regulatory requirements.
• Acquires and maintains knowledge of current local and international regulatory and legislative requirements and trends to ensure that advice and appropriate technical support on all quality/compliance related matters are provided to the site. Also, ensures Good Engineering Practices are followed according to GAMP, ISPE, and Seqirus standards.

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.

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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