Quality Control Officer

Job Description

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

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

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

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