QC Immunology Analyst - Data Integrity and Validation

CSL Vifor; Holly Springs, Northern (NC, KY); Hybrid; USD 85,000 - 105,000; Full time

Job summary

CSL Vifor is seeking a QC Analyst (Immunology- Biochemistry) to support release testing and review laboratory data. You will ensure CSL Seqirus samples are collected, tested, and documented per quality requirements, with results validated and traceable to records and systems.

The role involves cross-training, potential method validation tasks, and participation in lean lab initiatives. Strong GMP, data integrity, and biochemistry assay experience are essential for success.

Qualifications

• 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.

Responsibilities

• Performs testing and related tasks without errors per SOPs and protocols within Immunology/Biochemistry.
• Properly documents test results in appropriate records and computer systems.
• Ensures compliance with legal regulations, health and safety, and regulatory requirements.
• Participates in lean lab operation, 6S layout, preventive action and continuous improvement.
• Participates in cross-training to support staff availability within QC.
• May perform additional shift work to support operations.
• Writes and/or revises applicable procedures as required.
• Authors or leads deviation and invalid assay assessments.
• Performs peer review of data.
• Develops expertise in assigned assays/techniques.
• Provides informal guidance to other team members and shares knowledge.

Skills

Biochemistry assays

GMP compliance

Data integrity

Analytical instrumentation

Aseptic technique

GLIMS experience

Communication & multitasking

Education

Bachelor’s degree in Biochemistry or equivalent

Tools

GLIMS

Job description

CSL Vifor is seeking a QC Analyst (Immunology- Biochemistry) to support release testing and review laboratory data. You will ensure CSL Seqirus samples are collected, tested, and documented per quality requirements, with results validated and traceable to records and systems.

The role involves cross-training, potential method validation tasks, and participation in lean lab initiatives. Strong GMP, data integrity, and biochemistry assay experience are essential for success.