Quality Control Executive

Position: Quality Control Executive

Company: Boditech Med India Pvt. Ltd.

Location: Jhajjar, Haryana, INDIA

Experience: 1-2 Years

Salary: Not disclosed

Job description, roles and responsibilities:

Boditech Med India Pvt. Ltd., the wholly owned subsidiary of Boditech Med Inc., South Korea is seeking an Quality control Executive for its In Vitro Diagnostic (IVD) devices manufacturing factory in the Reliance Model Economic Township Industrial Area at Jhajjar in Haryana State.

Role & responsibilities

1. Job Purpose

To perform routine quality control testing and inspection of raw materials, components, in-process materials, and finished products in accordance with approved specifications, test methods, SOPs, and quality system requirements.

2. Key Responsibilities

• Perform QC testing and inspection of raw materials, components, in-process materials, and finished goods as per approved specifications and test methods.
• Conduct routine testing of IVD products/reagents as per approved SOPs and protocols.
• Perform sampling of materials and products as per approved sampling procedures.
• Review test results against approved specifications and acceptance criteria.
• Prepare and maintain QC test reports, worksheets, logbooks, and analytical records.
• Ensure proper documentation in accordance with Good Documentation Practices (GDP).
• Handle and maintain laboratory instruments and equipment in proper working condition.
• Perform routine checks, calibration verification, and preventive maintenance of QC equipment as applicable.
• Prepare and maintain standard solutions, reagents, controls, and other laboratory materials as required.
• Ensure proper identification, labeling, storage, and traceability of samples and tested materials.
• Report Out-of-Specification (OOS), Out-of-Trend (OOT), abnormal results, and other quality issues immediately to the QC/QA team.
• Support OOS investigations, deviation investigations, RCA and CAPA activities.
• Support validation and verification of analytical/test methods where required.
• Participate in stability studies and product performance evaluation activities as assigned.
• Coordinate with Production, QA, Warehouse, and other departments regarding quality-related issues.
• Maintain laboratory housekeeping, safety, hygiene, and 5S standards.
• Ensure proper handling and disposal of laboratory waste as per applicable procedures.
• Support internal, customer, regulatory, and certification audits by providing required QC records and information.
• Ensure compliance with applicable ISO 13485, GMP, SOPs, and company quality requirements.

3. Qualification

• B.Sc./M.Sc. in Biotechnology, Microbiology, Chemistry, Life Sciences, or related discipline.
• B.Tech/M Tech Biotechnology

4. Experience

• 12 years of relevant experience in QC/Quality Control.
• Experience in In Vitro Diganostics
• Candidates with relevant laboratory/internship experience may be considered based on technical knowledge.

5. Required Skills

• Good understanding of Quality Control and laboratory practices.
• Knowledge of basic analytical and laboratory testing techniques.
• Good understanding of specifications, test methods, SOPs, and acceptance criteria.
• Knowledge of GDP and data integrity principles.
• Basic understanding of OOS, OOT, deviation, RCA, and CAPA.
• Good documentation and reporting skills.
• Good analytical and problem-solving skills.
• Good knowledge of MS Excel and MS Office.
• Ability to work independently as well as in a cross-functional team.

6. Preferred Skills

• Experience in IVD/medical-device QC laboratory.
• Exposure to QC testing of reagents, controls, cartridges, or diagnostic products.
• Experience with laboratory instruments and equipment.
• Knowledge of ISO 13485 and GMP.
• Exposure to method verification/validation and stability studies.
• Experience with ERP/LIMS/QMS systems.

7. Key Performance Indicators (KPIs)

• Timely completion of QC testing as per production requirements.
• Accuracy and reliability of test results.
• Compliance with approved specifications and test methods.
• Accuracy and completeness of QC documentation.
• Timely reporting and investigation of OOS/OOT results.
• Proper maintenance and calibration status of laboratory equipment.
• Compliance with GDP, ISO 13485, GMP, and laboratory safety requirements.
• Timely support to Production and QA for batch release activities.