QC Specialist

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 were 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 peoples lives. Its a feeling of possibility creativity and purpose that inspires us every day.

You will be reporting to the Manager QC you will work onsite at our CSL Seqirus in Holly Springs NC location Monday-Friday during primary business hours. Benefits Include flexible hours M-F Onsite Caf Medical Dental Vision Life Insurance 401K and PTO available from your first day of hire. You will provide Technical SME support in the Quality Control Department at CSL Seqirus of the relevant laboratory for Assays and Equipment Compliance Records Regulatory Audits Deviation Management CAPAs Work Orders Reports Trends/Metrics and Document Creation/Revisions.

Major Accountabilities:

• Technical SME for all QC chemistry assays and equipment which will include raw material and product testing.
• Support all Analysts in the relevant laboratory with troubleshooting assisting with equipment breakdowns and assessing new equipment implementation.
• Help train Analysts in the laboratory as relevant laboratory assay SME.
• Be liaison between multiple internal organizations and laboratories to assist with and perform method validations/verifications.
• Lead deviation (DR) investigations to adequately identify root cause and implement appropriate corrective and preventative actions (CAPAs) to prevent recurrence and serve as QC liaison with other department investigation writers to ensure complete resolution. Employ standardized root cause analysis investigation tools and methodologies.
• Participate in continuous improvement programs/gemba kaizen events to eliminate unnecessary activities/maximize efficiency.
• Provide support with assigned business process systems (e.g. SAP LIMS EDMS LMS TrackWise Veeva etc.).
• Responsible for the Work Order Tracking system for tracking and coordinating the initiation execution and completion of work orders.
• SME input on QC Change Control Evaluation and Implementation Actions Corrective Actions /Preventative Actions (CAPAs) and Document revision/Periodic Review workflows to support the Quality Control department.
• Comply with policies and procedures to maintain compliance with legal regulations health and safety and regulatory requirements as written.
• Review and analyze trend reports to identify areas requiring additional action (e.g. quarterly reports APQR invalids OOS/OOT).
• Support departmental metrics and key performance indicators (KPIs) by attendance through QCOLT for Senior leadership review.
• Be the relevant laboratorys technical SME during regulatory and self-inspection audits according to all cGMP regulatory (e.g. USP/EP) and Seqirus Quality Manual requirements.

Minimum Qualifications:

• Bachelors degree and 3 years experience or equivalent (minimum)
• Basic knowledge of cGMP and FDA requirements
• Knowledge of Laboratory Systems and Investigation/Deviation/CAPA writing is desirable
• Knowledge of HPLC UPLC Raw Materials testing and USP/EP Compendia preferred

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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 whats available to you as a CSL Seqirus employee.

About CSL Seqirus

CSL Seqirus is part ofCSL. As one of the largest influenza vaccine providers in the world CSL Seqirusis a major contributor to the prevention of influenza globally and a transcontinental partner in pandemic preparedness. With state-of-the-art production facilities in the U.S. the U.K. and Australia CSL Seqirus utilizes egg cell and adjuvant technologies to offer a broad portfolio of differentiated influenza vaccines in more than 20 countries around the world.

We want CSL Seqirus to reflect the world around us

At CSL Inclusion and Belonging is at the core of our mission and who we are. It fuels our innovation day in and day out. By celebrating our differences and creating a culture of curiosity and empathy we are able to better understand and connect with our patients and donors foster strong relationships with our stakeholders and sustain a diverse workforce that will move our company and industry into the future. Learn more Inclusion and Belonging CSL.

Do work that matters at CSL Seqirus!

Watch our On the Front Line video to learn more about CSL Seqirus