Qc Microbiologist

**Job Title**: QC Microbiologist - Medical Devices
**Department**: Quality Control (QC)
**Reports To**: QC Manager / Quality Head

**Job Type**: Full-time

**Job Summary**:
We are seeking a **QC Microbiologist** to ensure the highest microbiological quality standards in our **medical devices manufacturing** process. The role involves conducting microbiological testing, sterility validation, and environmental monitoring to comply with **ISO 13485, US FDA, and GMP** regulations.

**Key Responsibilities**:
**Microbiological Testing & Analysis**:

- Perform **bioburden testing, endotoxin testing, and sterility testing** for medical devices.
- Conduct **microbial identification** and growth promotion testing.
- Validate and verify sterilization processes (Gamma, ETO, Steam).

**Environmental Monitoring (EM)**:

- Conduct **air, water, and surface sampling** in cleanrooms and controlled environments.
- Monitor viable & non-viable particulate counts and ensure compliance with regulatory standards.

**Sterility Assurance & Compliance**:

- Ensure compliance with **ISO 13485, GMP, FDA, and other regulatory standards**.
- Maintain sterility assurance and contamination control measures.
- Support sterilization validation studies, including **D-value & biological indicators assessment**.

**Documentation & Reporting**:

- Maintain **QC records, test reports, and investigation summaries**.
- Support audits and inspections by preparing microbiological compliance documentation.
- Conduct risk assessments related to microbiological contamination.

**Equipment Calibration & Maintenance**:

- Ensure proper functioning and calibration of **incubators, autoclaves, particle counters, and sterility isolators**.
- Perform routine maintenance and qualification of microbiology laboratory equipment.

**Qualifications & Skills**:
**Education**:

- Bachelor's/Master’s degree in **Microbiology, Biotechnology, or Life Sciences**.

**Experience**:

- 2+ years of experience in microbiology **QC for medical devices, pharmaceuticals, or biotechnology**.

**Technical Skills**:

- Hands-on experience with **bioburden, endotoxin, and sterility testing**.
- Knowledge of **ISO 13485, FDA 21 CFR Part 820, GMP, and sterility validation**.
- Experience with **cleanroom classifications and environmental monitoring**.

**Soft Skills**:

- Strong analytical and problem-solving abilities.
- Attention to detail and adherence to SOPs.
- Effective communication and documentation skills.

**Why Join Us?**
- Be part of an **innovative medical device** company driving quality and safety.
- Work with state-of-the-art microbiology testing technologies.
- Opportunity to grow in a dynamic and regulatory-compliant environment.

**Job Types**: Full-time, Permanent

Pay: ₹11,197.80 - ₹35,000.00 per month

**Benefits**:

- Paid sick time
- Paid time off

Schedule:

- Fixed shift
- Morning shift

**Experience**:

- total work: 2 years (preferred)

Work Location: In person