Specialist II/III, QA

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.

You will be a member of the QC team and report to Manager of Quality the at the Holly Springs site. Benefits Include Outdoor Amenities, Onsite Café, Medical, Dental, Vision, Life Insurance, 401K with a 6% match, and PTO available from your first day of hire.

Responsibilities:

• Release of manufactured material, including intermediates, virus seed and Drug substance
• Ensure that all aspects of drug substance/drug product comply with the requirements of the Seqirus Quality policies and meet all relevant cGMP regulatory requirements
• Support SAP Material builds process
• Support batch release team through completion of Lot Release Protocols (LRPs) and any other release task
• Ability to identify non-compliances impacting release and report as appropriate for resolution
• Responsible for author, review and approval of documents such as Standard Operating Procedures (SOP's), protocols/reports, work instructions etc. within the Electronic Document management System (EDMS) and ensuring they align with corporate and regulatory requirements.
• Support for Quality Management Systems for Change controls, Deviations and Product complaints (PTC's)
• Ability to train and coach others within the department.
• Support regulatory inspections as required

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
• Experience with SAP

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

Location: Holly Springs, NC, US

Posted Date: 9/27/2024