Quality Control Engineer

The QC Microbiologist is responsible for performing microbiological testing to support product quality, safety, and compliance with regulatory requirements. This role ensures that raw materials, in-process samples, finished products, and manufacturing environments meet established microbiological specifications in accordance with GMP and regulatory standards.

Key Responsibilities

Perform routine and non-routine microbiological testing, including:

Bioburden testing

Sterility testing

Endotoxin (LAL/BET) testing

Microbial limits testing

Environmental monitoring (air, surfaces, personnel)

Prepare, maintain, and qualify culture media, reagents, and microbiological equipment

Identify microorganisms using approved methods (e.g., biochemical, rapid ID systems)

Monitor cleanrooms and controlled environments and trend data for compliance

Document all test results accurately following GMP and ALCOA+ principles

Investigate out-of-specification (OOS), out-of-trend (OOT), and deviation results

Support CAPA, root cause investigations, and continuous improvement activities

Participate in method validation, verification, and transfer activities

Ensure laboratory compliance with SOPs, cGMP, FDA, USP, EP, and ISO requirements

Support audits and inspections (internal, regulatory, and customer)

Qualifications

Bachelor’s degree & Master's in Microbiology, Biology, or related field

1–5 years of experience in a QC microbiology laboratory (depending on level)

Hands-on experience with GMP microbiology testing

Strong knowledge of aseptic techniques and contamination control

Familiarity with regulatory guidelines (FDA, USP <61>, <62>, <71>, <85>, EU GMP)

Ability to work independently and in a team environment

Preferred Skills

Experience in pharmaceutical, biotech, medical device, or food manufacturing

Knowledge of rapid microbiological methods

Experience with cleanroom operations

Strong data analysis, documentation, and troubleshooting skills

Working Conditions

Laboratory and cleanroom environments

May require shift work, weekends, or on-call support

Use of PPE and adherence to safety protocols required

• It is a Full Time తయారీ job for candidates with 0 - 2 years of experience.