Analyst I,II,III,IV - QC

CSL•Holly Springs, NC

1d•Onsite

About The Position

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.

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.

Nice To Haves

5+ years of laboratory experience preferred for advanced-level candidates.
Experience in a regulated environment preferred.
Advanced proficiency in performing biochemistry and/or molecular biology assays, including ELISA, BCA, SRID, and SDS-PAGE preferred for senior-level candidates.
Familiarity with aseptic techniques and laboratory information management systems (e.g., GLIMS) preferred.
Experience with procedure writing, data review, investigations, method validation, and method transfer activities is preferred for advanced-level candidates.

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.