Main Task

The Laboratory QA/QC Assistant supports the Quality Assurance and Quality Control team in conducting laboratory testing, inspection, sampling, documentation, and monitoring of raw materials, packaging materials, in-process materials, and finished products. The position ensures that laboratory activities are performed accurately and in accordance with company procedures, quality standards, Good Manufacturing Practices (GMP), and applicable regulatory requirements.

Work Breakdown

Laboratory Testing and Analysis

• Assist in the sampling and testing of raw materials, packaging materials, in-process products, and finished products.
• Perform routine physical, chemical, and basic microbiological tests as assigned and as applicable to the product.
• Conduct tests such as appearance, color, odor, pH, viscosity, specific gravity, and other established product specifications.
• Prepare laboratory samples, reagents, solutions, and testing materials.
• Operate and maintain laboratory equipment and instruments properly.
• Ensure laboratory test results are accurate, complete, and properly recorded.
• Immediately report out-of-specification (OOS), abnormal, or questionable results to the QA/QC Supervisor or Laboratory Head.

Quality Control and Inspection

• Assist in inspecting incoming raw materials and packaging materials according to approved specifications.
• Assist in monitoring in-process and finished products to ensure compliance with established quality standards.
• Verify that samples are properly identified, labeled, stored, and handled.
• Support product release activities by providing complete and accurate laboratory test results.

Documentation and Records

• Complete laboratory worksheets, test reports, logbooks, and other QA/QC records accurately and on time.
• Maintain proper filing and traceability of laboratory records and test results.
• Assist in the preparation and issuance of Certificates of Analysis (COA), when authorized.
• Ensure laboratory documents are properly controlled and readily available for review or audit.
• Report discrepancies, errors, and non-conformities in laboratory records.

Laboratory Safety and GMP

• Follow laboratory safety procedures when handling chemicals, samples, equipment, and laboratory materials.
• Maintain cleanliness, orderliness, and proper sanitation of the laboratory.
• Observe Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), and company quality procedures.
• Properly dispose of laboratory wastes in accordance with established procedures.
• Use appropriate personal protective equipment (PPE) at all times.

Equipment and Inventory

• Assist in the proper cleaning, calibration verification, and preventive maintenance of laboratory equipment.
• Report defective or malfunctioning laboratory instruments immediately.
• Monitor laboratory supplies, reagents, and consumables and report low-stock items.
• Ensure chemicals and laboratory materials are properly labeled and stored.

Other Duties

• Assist during internal, customer, and regulatory audits and inspections.
• Assist in compliance with the FDA.
• Support investigations of product quality issues, complaints, deviations, and non-conformities.
• Assist in stability testing and other laboratory studies as assigned.
• Perform other related duties that may be assigned by the QA/QC Supervisor, Laboratory Head, or Management.