Quality Control Specialist (QC) – Microbiological Culture Media

🎯 I. Job Objective

Ensure that the production environment, cleanroom, compounding–packaging areas, microbiological products, and blood collection tubes consistently meet quality requirements, biosafety standards, and GMP / ISO 17025 / ISO 14644 / ISO 13485 / ISO 9001 regulations.

Perform periodic environmental microbiological monitoring, culture media quality control, cleanroom validation, sterilization hygiene assessment, and blood collection tube quality inspection.

⚙️ II. Key Responsibilities

1. Production Environment & Cleanroom Monitoring

• Develop and implement microbiological environmental monitoring plans, including:
• Air monitoring (air sampling, settle plates)
• Surface monitoring (surface swab, contact plates)
• Personnel monitoring (fingerprint tests)
• Measure and record temperature, humidity, differential pressure, and particle counts according to ISO 14644 standards.
• Evaluate monitoring results against alert/action limits, prepare reports, and propose CAPA (Corrective and Preventive Actions) when limits are exceeded.

2. Culture Media Quality Control & Blood Collection Tube QC

• Perform sterility testing and growth promotion testing for culture media such as TSA, SDA, MacConkey, EMB, etc.
• Inspect blood collection tube quality.
• Verify solidification time, pH, clarity, color, and expiration date before use.
• Manage internally produced or externally purchased media batches, assign batch numbers, and monitor shelf life.
• Retain media samples and maintain testing logs.

3. Microbiological Testing of Products

• Collect samples for microbiological testing of finished products, raw materials, RO water, DI water, compressed air, personnel hands, and equipment surfaces.
• Perform microbiological testing including:
• Total Aerobic Microbial Count (TAMC)
• Total Yeast and Mold Count (TYMC)
• Coliform, E. coli, Pseudomonas, Staphylococcus, Salmonella, etc.
• Operate, calibrate, and maintain laboratory testing equipment such as incubators, biosafety cabinets, analytical balances, micropipettes, laminar airflow cabinets, and colony counters.

4. Sterilization Validation & Cleaning Verification Support

• Participate in verification and validation of sterilization methods such as VHP, Autoclave, UV, or chemical disinfectants.
• Perform residual chemical testing after equipment cleaning.
• Coordinate with QA and Maintenance teams during periodic cleanroom qualification, FFU checks, HEPA leak testing, and DOP testing.

5. Documentation & Reporting

• Prepare and maintain environmental monitoring records, test result reports, and microbiological trend charts.
• Submit periodic environmental monitoring reports to the QA Manager.
• Support documentation preparation for GMP / ISO audits and inspections.

Education:

Bachelor’s degree in Microbiology, Biology, Biotechnology, Environmental Science, or a related field.

Experience:

At least 1–2 years of experience working in a microbiology laboratory, pharmaceutical manufacturing, microbiology production, or environmental testing facilities.

Professional Knowledge:

Strong understanding of ISO 14644, GMP, GLP, ISO 17025 standards; familiar with microbiological testing methods.

Skills:

• Aseptic techniques and sterile operation
• Experience working with cleanroom equipment and laboratory instruments
• GLP-compliant documentation and record keeping
• Data analysis and interpretation

Personal Attributes:

Detail-oriented, honest, highly compliant, and responsible.

Salary: 8 - 12 million