What are the responsibilities and job description for the Analyst, QC position at CSL Seqirus?
Entity: CSL Seqirus
Job Category: Quality
Job Family: Quality Control
Job Type: Full Time
Location: HOLLY SPRINGS, North Carolina, United States
Employer Reference: R-283895
Job Description
QC Analyst (Immunology- Biochemistry)
Job 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
Responsibilities
Performs testing and associated tasks without errors per applicable SOPs and protocols within Immunology/Biochemistry function.
Properly documents test results in appropriates records and computer systems
Complies with policies and procedures in order to maintain compliance with legal regulations, health and safety, and regulatory requirements as written.
Participates in lean lab operation, 6S laboratory layout, preventive action & continuous improvement programs to reduce operating costs.
Participates and performs in cross-training to support staff availability within QC department.
May be required to perform additional shift work as required to support operations.
Writes and/or revises applicable procedures as required
Authors or may lead deviation and invalid assay assessments
Performs peer review of data
Develops expertise in assigned assays/techniques
May provide informal guidance and support to other team members and leverages own knowledge to others
Requirements
Bachelor’s degree in Biochemistry or equivalent
5 years of laboratory experience
5 years of GMPs, safety regulations and data integrity
Experience performing Biochemistry assays (ELISA, BCA, SRID, SDS-PAGE) required
Knowledge of analytical methods and related instrumentation
Knowledge of aseptic technique preferred
GLIMS experience preferred
Proficient in communication and multi-tasking
Will be required to have a flu shot and maintain yearly
#GTA
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.
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/.
Our Benefits
For more information on CSL benefits visit How CSL Supports Your Well-being | CSL.
You Belong at 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
Equal Opportunity Employer
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.
Benefits:
Maternity & Paternity Leave, Vacation & Paid Time Off, Health Insurance