Quality Control Analyst I

Quality Control Analyst I

Pay Range: $27.90hr - $32.90hr

The Quality Control Analyst I will perform routine quality testing activities in a QC laboratory environment while adhering to SOPs, cGMP, and regulatory requirements. The role involves supporting product testing, validation, stability programs, and contributing to quality control processes, documentation, and continuous improvement activities.

Requirement/Must Have:

• Bachelor’s degree in a Science field (Biology, Immunology, or related disciplines) or equivalent experience.
• 1–3 years of relevant experience in biology or immunology-based testing.
• Knowledge of cGMP, SOPs, and regulatory compliance requirements.
• Good mathematical skills and computer literacy.
• Strong attention to detail and ability to work with minimal errors.
• Strong verbal and written communication skills.

Experience:

• Experience performing routine QC laboratory testing in a regulated environment.
• Experience with immunology-based assays preferred.
• Experience in supporting production, validation, and stability testing programs.
• Experience working in a cGMP facility preferred.
• Experience with documentation, data review, and result evaluation.

Responsibilities:

• Perform routine quality control testing following SOPs, cGMP, and safety procedures.
• Conduct testing to support production, validation, and stability programs.
• Complete required documentation and laboratory records accurately.
• Perform sample preparation, testing, and product inspections.
• Operate and maintain QC laboratory equipment before and after use.
• Troubleshoot sample discrepancies and repeat assays when required.
• Perform peer review and verification of assay results.
• Maintain laboratory cleanliness and compliance standards.
• Support SAP, TrackWise, and LIMS system activities.
• Participate in team meetings, safety meetings, and training sessions.
• Support deviations, CAPAs, and change control processes.
• Report issues and assist in incident investigations as required.

Should Have:

• Experience with ELISA testing.
• Exposure to immunology-based laboratory techniques.
• Experience working in regulated QC environments.
• Familiarity with laboratory systems such as SAP, TrackWise, and LIMS.

Skills:

• Laboratory testing and quality control techniques.
• Immunology and biological assay knowledge.
• Data review and documentation skills.
• Strong organizational and communication skills.
• Ability to follow SOPs and regulatory procedures.
• Problem-solving and troubleshooting skills.
• Computer literacy and basic system handling (SAP, LIMS, TrackWise).

Qualification And Education:

• Bachelor’s degree in Biology, Immunology, Life Sciences, or related field preferred.
• 0–3 years of relevant laboratory experience acceptable.