Analyst, QC

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

Job summary

CSL Plasma in Holly Springs, NC is seeking a QC Analyst (Immunology- Biochemistry) to perform release testing and review laboratory data. You will ensure results are valid, accurate and documented per regulatory and corporate requirements, and support cross-training within the group.

Requirements include a Biochemistry degree, 5+ years of lab GMP experience, and hands-on experience with ELISA, BCA, SRID, SDS-PAGE, plus good communication skills.

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 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

Skills

GMP compliance

Analytical methods

Communication

Multitasking

Aseptic technique

Biochemistry assays

Education

Bachelor's degree in Biochemistry

Tools

GLIMS

Job description

3 DAYS AGO Full Time 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 B iochemistry 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

Location and Region

Holly Springs, North Carolina