Quality control officer

Astam Diagno · Rajasthan, 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, p H meter and analytical balance. Verify raw materials and components against approved specifications and supplier Co As. Prepare test reports, Co As 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