What are the responsibilities and job description for the QC Analyst II/ III (Microbiology) position at CSL?
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.
Reporting to the QC Team Leader you will be responsible for performing tasks associated with release testing and reviewing laboratory data. Secondary responsibilities include cross training of staff. You will be responsible for ensuring that Seqirus samples are collected, tested, and reviewed according to quality requirements and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. You may be required to perform or participate in tasks associated with method validation and transfers.
You will be on day shift: Monday-Friday
Responsibilities
Level will be determined based on years of experience.
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. 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. 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
Reporting to the QC Team Leader you will be responsible for performing tasks associated with release testing and reviewing laboratory data. Secondary responsibilities include cross training of staff. You will be responsible for ensuring that Seqirus samples are collected, tested, and reviewed according to quality requirements and results reported are valid, accurate, and documented per applicable regulatory and corporate requirements. You may be required to perform or participate in tasks associated with method validation and transfers.
You will be on day shift: Monday-Friday
Responsibilities
Level will be determined based on years of experience.
- Perform testing and associated tasks without errors per applicable SOPs and protocols.
- Comply with policies and procedures in order 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
- Perform shift-work as necessary to support manufacturing Participates and performs 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 Scientific discipline
- 3 years of laboratory experience OR equivalent
- Intermediate knowledge of GMPs, safety regulations and data integrity
- Intermediate knowledge of analytical methods and related instrumentation.
- GLIMS experience preferred
- Method verification/validation experience (sterility, endotoxin, bioburden) preferred
- Technical competencies: Bioburden testing, endotoxin testing (preferably Kinetic method), Sterility testing, growth promotion testing of microbiological media, identification of microbiological isolates
- Working knowledge of EM, water and clean steam collection, and gas sampling preferred.
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. 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. 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
