Microbiologist – QA / QC

Job Description: Microbiologist – QA / QC

Department: QA / QC

Designation: Microbiologist

Location: Sonipat, Haryana

Role Overview:

To perform microbiological testing, environmental monitoring, and sterility assurance for medical

device manufacturing processes, ensuring compliance with company quality standards and applicable

regulatory norms.

Key Responsibilities:

Environmental Monitoring & Sterility Assurance

Conduct microbiological monitoring of cleanrooms and controlled environments (air

sampling, settle plates, surface swabs, and personnel monitoring).

Ensure adherence to ISO Class requirements and maintain sterility levels as per company

and regulatory standards.

Perform routine microbial testing of purified water, raw materials, and finished goods.

2. Product & Process Testing

Perform bioburden, endotoxin (LAL), and sterility testing of medical devices and related

materials.

Support validation and monitoring of sterilization processes (ETO, Gamma) in

coordination with QA.

Maintain microbial cultures and perform microorganism identification when required.

3. Documentation & Compliance

Maintain accurate records of all microbiological testing and environmental monitoring

data.

Ensure documentation and procedures comply with ISO 13485 and CE marking

requirements applicable to Lars Medicare’s operations.

Support internal and external audits with relevant data and reports.

4. Equipment Calibration & Maintenance

Ensure all microbiological instruments (incubators, autoclaves, LAFs, colony counters,

etc.) are calibrated and in good working condition.

Maintain calibration certificates, equipment usage logs, and preventive maintenance

records.

5. Investigations & Continuous Improvement

Support root cause analysis (RCA) and implement corrective and preventive actions

(CAPA) for any microbial contamination or sterility failures.

Participate in training and continuous improvement programs related to microbiological

testing and environmental controls.

Qualifications & Skills

Education:

B.Sc. / M.Sc. in Microbiology, Biotechnology, or Life Sciences

Experience:

2–5 years of experience in microbiological testing, preferably in medical device, pharmaceutical,

or biotechnology manufacturing

Technical Skills:

Experience in bioburden, sterility, endotoxin (LAL), and environmental monitoring

Familiarity with sterilization processes (ETO/Gamma)

Understanding of ISO 13485 quality systems and CE requirements

Basic computer and documentation skills (Excel, ERP, LIMS preferred)

Soft Skills:

Strong analytical and documentation abilities

Attention to detail and precision

Teamwork and communication skills

Commitment to quality, compliance, and safety

Working Conditions :-

Laboratory-based role within a controlled and cleanroom environment.

Requires adherence to safety, hygiene, and gowning protocols.

Close coordination with Quality Assurance and Production departments.

To Know More Whatsapp/Contact - 9482744952

Email - careers@rareminds.in

Job Type: Full-time

Pay: ₹25,000.00 - ₹35,000.00 per month

Work Location: In person