Qc Team Lead - Chemistry

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 QC Team Lead will be reporting to the Manager, QC. You will ensure the QC Chemistry team goals are achieved and they have developmental opportunities, provide direction for activities to ensure compliance with regulatory requirements and company SOPs and represent the team when needed during meetings. 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 Café, Medical, Dental, Vision, Life Insurance, 401K, and PTO available from your first day of hire.

Responsibilities

• Provide leadership on safety and create a positive safety culture. Ensure safety is always on the front line.
• Schedule the activities of the team following the Lean Lab solution; monitor and approve time and attendance; ensure training/competence completion; perform 1-1s and development planning; manage performance of all associates. Monitor associated KPIs being used to adapt plans accordingly.
• Approve data generated from testing and to bring to the attention of the Team Manager and other site personnel test results and any trends, out of specification results. Also perform the required transactions to release materials.
• Ensure that the maintenance and qualification of the specified laboratory and equipment within is up to date and at the required GMP standards. To ensure the use only of approved and validated test processes.
• Co-coordinate department cGMP systems, such as deviation management, closure of corrective and preventative actions, change controls and SOPs.
• Participate in improvement project teams where required driving quality decisions and provide advice and technical support where required. Coordinate completion of any resulting activities.
• Troubleshoot in the resolution of testing problems involving your team and customers/suppliers. Demonstrate problem solving within cGMP constraints and align with best practice.
• Track the team ensuring that mandatory training is in place. To encourage performance of staff through training, feedback every two months and development planning together with the Team Manager

Minimum Qualifications:

• Bachelor degree in a relevant scientific discipline (Chemistry, Biochemistry, etc.)
• 5 years' quality control experience in the pharmaceutical/biotech/or other regulated industry. Experience with data integrity in a GMP lab.
• Leadership experience in past roles helps in the success of this position
• Experience with multi-disciplined team environment
• Experience in GLIMS Labware system
• Direct interaction with regulatory agencies
• Knowledge of current Good Manufacturing Practices (cGMP) principles
• Experience with Raw Material testing using both USP and internal methods. Experience with wet chemistry, Karl Fischer for moisture analysis, manual and automatic titration, FTIR, Raman, HPLC/UPLC, and UVvis.

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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