QC Analyst, (Immunology- Virology)

CSL Plasma; Holly Springs (NC); On-site; USD 42,000 - 66,000; Full time

Job summary

CSL Seqirus is seeking a full-time Lab Analyst in Holly Springs, NC to perform release testing and review laboratory data to ensure quality compliance. The role ensures results are valid, accurate and documented per regulatory requirements.

The candidate will work Mon-Fri 8am-5pm, with occasional weekend shifts and potential shift work. Requirements include a Bachelor's degree in Molecular Biology or related field, 0-3 years’ experience, GMP knowledge, data integrity, and experience with

Qualifications

• Bachelor's degree in Molecular Biology, Biology, or related field.
• 0-3 years 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.

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.

Skills

Quality compliance

Data entry accuracy

Cross-training

Education

Bachelor's degree in Molecular Biology

Tools

GLIMS

PCR

Job description

NEW Full Time 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

Location/Region: Holly Springs, North Carolina