Quality Control Microbiologist

6 hours ago

Changodar Ahmedabad Gujarat, India Osteon Lifesciences Pvt. Ltd. Full time

The **Microbiologist** will be responsible for ensuring the microbiological quality and sterility assurance of orthopedic implants, surgical instruments, and cleanroom environments. The role involves monitoring sterilization processes, performing environmental and bioburden testing, and supporting validations in compliance with ISO 13485 and regulatory standards.

**Key Responsibilities**
- Perform **bioburden testing**, **sterility testing**, and **endotoxin (LAL) tests** on implants and instruments.
- Conduct **environmental monitoring** of cleanrooms (settle plates, air sampling, surface & personnel monitoring).
- Validate **sterilization cycles (ETO/Gamma)** and maintain sterilization records.
- Support validation and routine control of **cleanroom facilities**.
- Ensure adherence to **ISO 13485**, **ISO 14644**, and other relevant standards.
- Prepare and maintain microbiological test reports, SOPs, and control documents.
- Investigate microbial contamination incidents and implement corrective actions.
- Support audits and inspections by regulatory bodies or clients.

**Qualifications & Experience**
- **Education**: B.Sc. / M.Sc. in Microbiology / Biotechnology.
- **Experience**: 2-5 years in microbiology or sterility assurance in a **medical device, pharma, or orthopedic implant**industry.
- **Knowledge**:

- Microbial testing methods (USP, ISO standards).
- Environmental monitoring procedures.
- Cleanroom and sterilization process validation.

**Key Skills**
- Strong documentation and analytical skills.
- Familiarity with laboratory instruments and aseptic techniques.
- Attention to detail and GMP compliance mindset.
- Ability to support audits and technical documentation.

Pay: ₹20,000.00 - ₹35,000.00 per month

Work Location: In person

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