Job Summary
The Microbiologist Quality Assurance is responsible for ensuring microbiological quality and safety of products, raw materials, utilities, and manufacturing environments. This role supports compliance with regulatory standards, GMP, and company quality systems through routine testing, monitoring, investigations, and documentation.
Key Responsibilities
- Perform microbiological testing of raw materials, in-process samples, finished products, and stability samples.
- Conduct environmental monitoring (air, surface, water, and personnel) in production and controlled areas.
- Monitor and trend microbiological data to identify deviations and risks.
- Investigate out-of-specification (OOS), out-of-trend (OOT), and contamination events; recommend and implement CAPA.
- Review and approve microbiological test results and reports.
- Ensure compliance with GMP, GLP, ISO, FDA, and other applicable regulatory requirements.
- Prepare, review, and maintain SOPs, protocols, and validation documents related to microbiology.
- Support method validation, verification, and transfer activities.
- Participate in internal and external audits; respond to audit observations related to microbiology.
- Ensure proper handling, calibration, and maintenance of microbiology laboratory equipment.
- Train production and laboratory personnel on microbiological practices, hygiene, and aseptic techniques.
- Support change control, risk assessments, and quality improvement initiatives.
Qualifications & Experience
- Bachelors or masters degree in microbiology, Biotechnology, Life Sciences, or a related field.
- 0-years of experience in a QA Microbiology role within pharmaceutical, food, cosmetic, or biotechnology industries.
- Strong knowledge of microbiological techniques, sterility assurance, and contamination control.
- Experience with environmental monitoring and cleanroom practices.
- Familiarity with regulatory guidelines (GMP, ISO 14644, USP, EP, FDA).
- Experience with documentation, deviation management, and CAPA systems.
Skills & Competencies
- Strong analytical and problem-solving skills
- Attention to detail and data integrity
- Good documentation and report-writing skills
- Ability to work independently and in cross-functional teams
- Effective communication and training skills
- Proficiency in MS Office and laboratory information systems (LIMS)
Working Conditions
- Laboratory and manufacturing floor environment
- May require shift work or on-call support
- Use of PPE and adherence to safety protocols
