QC Specialist (Compliance Investigator)

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 join as a QC Specialist and will be reporting to the Manager, Quality Control and will work onsite at our CSL Seqirus site in Holly Springs, NC location. As the QC Specialist, you will provide technical expertise related to the process, equipment, and business systems that drive strategic improvements in the services provided to our customers. You will also support as a subject matter expert representing Seqirus during routine audits.

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

• Lead deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent recurrence.
• Utilize standardized root cause analysis, investigation tools and methodologies.
• Use Investigation and Deviation systems for managing QC investigations, tracking statuses, leading investigations teams and serve as QC liaison with other department investigation writers to ensure complete and timely resolution
• You will work with QA on investigations.
• Understand and approve abort/invalids in GLIMs and OOS procedure and perform and review phase 1 investigations.
• Initiate and perform EDMS workflows.
• Complete change control, self inspection, and CAPA Actions.
• Present and/or shows QC tests, validations, and/or QA events to both internal and external auditors. Lead process for responding to inquiries from auditors.
• Lead routine team meetings, track metrics (KPIs) and project statuses.
• Deliver presentations to the team and department and cross-functional groups.

Minimum Requirements:

• Bachelor's degree required. Degree in a science discipline preferred.
• 3+ years related industry experience required, including 3+ years' experience in pharmaceutical/biotech mfg operations or QC technical role.
• 1+ years of experience with ownership of deviations
• 2+ years of experience with RCA tools
• Experience assisting or leading investigations a plus
• Experience assisting or leading inspections a plus

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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