Quality Control Officer

Astam Diagno · India

JOB DESCRIPTION | QC EXECUTIVE Astam Diagnostics Pvt. Ltd.

IVD & Medical Devices Manufacturing Plant

Department: Quality Control

Reports To: QC Manager / QC Team Lead

Location: Manufacturing Plant, Bhiwadi, Rajasthan

Employment Type: Full-Time, Permanent

Experience: 1–4 Years

Education: B.Sc./M.Sc./B.Tech./B.E. in relevant discipline

Salary : 30,000- 50,000( negotiable)

Role Summary

Responsible for day-to-day QC activities including raw material, in-process and finished-product testing, documentation, equipment handling, OOS investigation and compliance with approved SOPs and quality standards.

Key Responsibilities

• Perform incoming, in-process and finished-product inspection and testing.
• Conduct relevant IVD, rapid test/LFA, immunoassay, biochemical, chemical and functional tests.
• Operate laboratory equipment including spectrophotometer, ELISA reader, pH meter and analytical balance.
• Verify raw materials and components against approved specifications and supplier CoAs.
• Prepare test reports, CoAs and maintain QC records as per GDP.
• Identify and report OOS, OOT, deviations and non-conformities.
• Support RCA, CAPA, stability studies and method validation activities.
• Maintain equipment logs, calibration records and laboratory documentation.
• Ensure proper sample identification, storage and traceability.
• Support internal, customer and regulatory audits.
• Coordinate with QA, Production, R&D and Engineering teams for quality-related issues.

Qualifications

• 1–4 years of QC experience in IVD, diagnostics, medical devices, pharmaceutical or related manufacturing.
• Practical knowledge of laboratory testing and QC documentation.
• Knowledge of ISO 13485, GMP/GDP and basic QMS requirements.
• Experience with rapid diagnostic/LFA, ELISA or immunoassay testing will be preferred.
• Knowledge of OOS/OOT, CAPA and RCA is preferred.
• Good analytical, documentation and communication skills.

Key Competencies

QC Testing | IVD/LFA | Laboratory Instruments | GDP | OOS/OOT | CAPA & RCA | Documentation | ISO 13485 | Problem Solving | Attention to Detail