Analyst, QC

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

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.

Watch our ‘On the Front Line’ video to learn more about CSL Seqirus