Analyst, QC

CSL; Holly Springs (NC); On-site; USD 65,000 - 90,000; Full time

Job summary

CSL Seqirus in the United States is seeking a QC Analyst (Immunology- Biochemistry) to perform release testing and review laboratory data. The role ensures results are valid, accurate and documented per regulatory requirements.

The position includes potential trainer duties for upper-level analysts and participation in method validation and transfers. Working days are Monday to Friday with 8am–5pm hours; off-shift coverage for STAT testing may be required.

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.

Responsibilities

• Performs testing and associated tasks without errors per SOPs and protocols.
• Documents test results in records and computer systems.
• Maintains compliance with health, safety and regulatory requirements.
• Participates in lean lab operation and 6S layout.
• Cross-trains to support staff availability in QC.
• Writes or revises procedures as required.
• Performs peer review of data.
• Develops expertise in assigned assays/techniques.

Skills

Laboratory techniques

Documentation

Analytical thinking

GMP compliance

Cross-training

Education

Bachelor’s degree in Biochemistry or equivalent

Tools

ELISA

BCA

SRID

SDS-PAGE

Job description

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.

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

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