Entity: CSL Seqirus
Job Category: Quality
Job Family: Quality Control
Job Type: Full Time
Location: Holly Springs, North Carolina, United States
Employer Reference: R-284846
Purpose
Primary responsibilities for this position include performing tasks associated with release testing and reviewing laboratory data. The analyst will be responsible for ensuring that CSL Seqirus samples are collected, tested, and reviewed according to quality requirements. This position will ensure results are valid, accurate and documented per applicable regulatory and corporate requirements. If Upper Analyst position, the analyst will become a certified trainer to develop cross training with the group. The analyst will be required to perform and participate in tasks associated with method validation and transfers.
- Days – Monday – Friday Hours – (8am – 5pm)
- Off shift coverage required for STAT testing
Job level will be determined based on years of relevant experience to our processes and equipment
Responsibilities
- Perform Immunology/Biochemistry testing and related laboratory activities in accordance with approved SOPs, protocols, and quality requirements.
- Accurately document, review, and maintain test results and laboratory records in applicable systems to ensure data integrity and regulatory compliance.
- Adhere to GMP, safety, regulatory, and company policies while maintaining a compliant laboratory environment.
- Support lean laboratory operations, continuous improvement initiatives, preventive actions, and 6S practices to enhance efficiency and quality.
- Participate in cross-training activities and support departmental staffing needs, including off-shift or additional shift coverage as required.
- Perform peer review of laboratory data and assist in ensuring the accuracy and timely completion of testing activities.
- Develop expertise in assigned assays, techniques, and laboratory processes while serving as a resource to team members.
- Author and revise laboratory procedures, technical documents, and related records as needed.
- Support or lead investigations related to deviations, invalid assays, and other quality events.
- Participate in method validations, method transfers, and implementation of new laboratory processes.
- Provide training, mentorship, and technical guidance to team members, including serving as a certified trainer when qualified.
Requirements
- Bachelor’s degree in Biochemistry, Biology, Chemistry, or a related scientific discipline.
- 1+ years of laboratory experience required; 5+ years of laboratory experience preferred for advanced-level candidates.
- Knowledge of GMP requirements, laboratory safety regulations, and data integrity principles; experience in a regulated environment preferred.
- Experience performing biochemistry and/or molecular biology assays, including ELISA, BCA, SRID, and SDS-PAGE; advanced proficiency preferred for senior-level candidates.
- Working knowledge of analytical laboratory methods, instrumentation, and troubleshooting techniques.
- Familiarity with aseptic techniques and laboratory information management systems (e.g., GLIMS) preferred.
- Strong communication, organizational, documentation, and multitasking skills, with the ability to collaborate across teams and provide training or guidance to others.
- Experience with procedure writing, data review, investigations, method validation, and method transfer activities is preferred for advanced-level candidates.
- Ability to receive and maintain annual influenza vaccination as required.
Different qualifications or responsibilities may apply based on local legal and/or educational requirements. Refer to local job documentation where applicable.
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.
To learn more about CSL, CSL Behring, CSL Seqirus and CSL Vifor visit https://www.csl.com/ and CSL Plasma at https://www.cslplasma.com/.
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
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.
To learn more about inclusion and belonging visit https://www.csl.com/careers/inclusion-and-belonging
CSL is an Equal Opportunity Employer. If you are an individual with a disability and need a reasonable accommodation for any part of the application process, please visit https://www.csl.com/accessibility-statement.
