Quality Control Analyst I

• 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.
• 0 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.