QC Analyst

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.

Primary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data within the QC Microbiology department. The analyst will ensure that CSL Seqirus samples are collected, tested, and reviewed according to quality requirements. You will ensure results are valid, accurate and documented per applicable regulatory and corporate requirements.

Days - Wednesday - Saturday (10 hour)

Responsibilities

• Perform testing and associated tasks without errors per applicable SOPs and protocols.
• Comply with policies and procedures to maintain compliance with legal regulations, health and safety, and regulatory requirements as written
• Participate in lean lab operation, 6S laboratory layout, preventive action & continuous improvement programs to reduce operating costs
• Performs shiftwork as necessary to support manufacturing
• Participate and perform in cross-training to support staff availability within QC department
• Develop and maintain SOPs
• Develop expertise in assigned assays/techniques
• Author deviation and invalid assay assessments
• May be required to perform shift work as required to support operations

• Bachelor's degree in Microbiology, Biology, Biochemistry, or equivalent preferred.
• Minimum of 1-5 years of laboratory experience OR equivalent
• One year of GMP, safety regulation and data integrity experience preferred
• Knowledge and/or experience performing microbiology assays; endotoxin, bioburden, and sterility is preferred.
• Knowledge of analytical methods and related instrumentation.
• Knowledge of aseptic technique and environmental monitoring procedures/practices (air, surface, personnel, and water)
• LIMS experience preferred