Analyst III, QC

CSL Vifor; Holly Springs (NC); On-site; USD 52,000 - 70,000; Full time

Job summary

CSL Seqirus in Holly Springs, NC seeks an Analyst, QC Chemistry to perform raw material and product release testing in a GMP environment. This onsite role supports QC sample testing and ensures data integrity and regulatory compliance.

The role follows SOPs and documentation standards, with responsibilities including result reporting, adherence to health and safety requirements, and participation in continuous improvement initiatives in the lab.

Qualifications

• Bachelor’s degree in a scientific discipline required.
• Experience with HPLC/UPLC chromatography; Empower experience preferred.
• Experience testing with compendia (USP/EP) or knowledge of compendia.
• Knowledge of analytical methods and related instrumentation.
• Knowledge of GMPs, laboratory documentation, and data integrity.
• One year of relevant industry experience required.
• GLIMS Labware experience is preferred.

Responsibilities

• Performs raw material compendia chemistry testing for QC samples.
• Performs product testing related to chemistry tests for QC samples.
• Performs GMP testing and related tasks per SOPs and protocols.
• Complies with procedures to maintain compliance with regulations, safety, and quality.
• Participates in lean lab operation and continuous improvement programs to reduce costs.

Skills

HPLC/UPLC

Empower experience (preferred)

Compendia testing (USP/EP)

Analytical methods & instrumentation

GMPs, documentation, data integrity

1 year relevant experience

GLIMS Labware experience

Education

Bachelor’s degree in a Scientific discipline

Tools

Empower

GLIMS Labware

Job description

Analyst, QC Chemistry

Job Purpose: Primary responsibilities for this position include performing tasks associated with raw material and product release in a GMP environment. This analyst will ensure that CSL Seqirus samples are testing according to quality requirements, and results reported are valid, accurate, and documented per applicable regulatory requirements. This role works standard business hours, Monday - Friday, onsite five days a week.

The Role:

• Performs raw material compendia chemistry testing for QC Samples.
• Perform product testing related to chemistry tests for QC Samples.
• Performs GMP testing and associated tasks without errors per applicable SOPs and protocols.
• Comply with 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.

Minimum Requirements:

• Bachelor’s degree in a Scientific discipline is required.
• Experience with HPLC/UPLC chromatography; Empower experience preferred.
• Experience testing with compendia (USP/EP) or knowledge of compendia.
• Knowledge of analytical methods and related instrumentation.
• Knowledge of GMPs, laboratory documentation, and data integrity.
• One year of relevant industry experience required.
• GLIMS Labware experience.