QC Analyst, (Immunology- Virology)

CSL; Holly Springs (NC); On-site; USD 55,000 - 75,000; Full time

Job summary

CSL Seqirus in Holly Springs, NC seeks an Analyst to perform release testing and review laboratory data to ensure samples are collected, tested, and reviewed per quality requirements. The role ensures results are valid, accurate and documented per regulatory standards.

Responsibilities include documenting results, maintaining compliance, and supporting lean lab operations. Weekend shifts may be required to support operations and quality initiatives.

Qualifications

• Bachelor’s degree in Molecular Biology, Biology, or related field.
• 0–3 years of experience preferred.
• Knowledge of GMPs, safety regulations and data integrity preferred.

Responsibilities

• Performs testing and associated tasks without errors per applicable SOPs and protocols within Immunology/Virology function.
• Properly documents test results in appropriate records and computer systems.
• Complies with policies and procedures 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 in cross-training to support staff availability within QC department.

Skills

GMP knowledge

Data integrity

Documentation

Cross-training

Education

Bachelor’s degree in Molecular Biology

Tools

GLIMS

Job description

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.

Days – Monday – Friday

Hours – (8am – 5pm)

Weekend work is on occasion required

Responsibilities

• Performs testing and associated tasks without errors per applicable SOPs and protocols within Immunology/Virology function.
• Properly documents test results in appropriate 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.

Requirements

• Bachelor’s degree in Molecular Biology, Biology, or related field
• 0-3 year experience
• Knowledge of GMPs, safety regulations and data integrity preferred
• Experience with maintaining and passaging mammalian cell culture preferred
• Experience performing Virus Titer assays, Residual Infectious Virus assays, PCR, DNA extraction, and other virology-based testing methods is preferred
• Knowledge of analytical methods and related instrumentation
• Knowledge of aseptic technique preferred
• GLIMS experience preferred
• Will be required to have a flu shot