RESPONSIBILITIES

1. Performs microbiological sampling and testing of finished goods, raw materials, water samples, WIP samples and C&S swabs and environmental samples in accordance with standard procedures.
2. Be responsible for environmental monitoring program for both lab and plant.
3. Ensure the media QC is carried out in accordance with QMIC 0015 and QMIC 0016.
4. Serve as site MPI user and update the finished goods MSI data and water MSI into global MPI system.
5. Plan and maintain enough stocks of operational supplies such microbiological media, reagents, API kits and standard culture.
6. Understand and use basic laboratory safety equipment and instructions, precautions in handling reagents, and disposal of microbiological waste according with local environmental regulations.
7. Understand and precisely follow written lab procedures, global methods, local methods and published standard or compendia sources.
8. Participates in failure investigations to collect the necessary samples when appropriate. Acquires basic knowledge of plant floor operations and equipment.
9. Apply appropriate methodologies and data interpretation techniques to assist in overcoming technical difficulties and promote continuous improvement.
10. Perform or assist the vendor during the installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ) of the analytical instruments.
11. Maintains the laboratory quality control systems to assure validity of data.
12. Maintain accurate, up to date and concise laboratory records.
13. Maintain awareness of regulatory and GMP requirements relevant to job responsibilities.
14. Maintain accurate, up to date and concise laboratory notebooks and records.
15. Perform other related duties as assigned by supervisor.
16. Maintain working area, instruments, equipment clean, neat and tidy.

AUTHORITIES/DECISIONS
1. Sampled and testing key product characteristics of Raw Materials, Work In Process and Finished Goods and reporting of testing problem, non-conforming to Supervisor.
2. Participation continuous improvement in function as part of plant’s safety and quality.
3. Serve as second in line for Team Leader Microbiology in her absence.

MAGNITUDE OF RESPONSIBILITY

1. Ultimate responsibilities for sampling, lab testing of microbiological samples.

JOB SPECIFICATION
1. EDUCATION: Graduate in Microbiology or other related biological science
2. MINIMUM EXPERIENCE : Not specified
3. SKILL/KNOWLEDGE : Basic Microbiology and GMP, Basic Computer skill and Understanding of English
4. BASIC TRAINING REQUIRED :
Functional : Basic GMP/Micro/ QA/QC knowledge, Basic product knowledge, OJT training, Safety at work.
Leadership/management : Not specified.