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Quality Control Microbiology Analyst (Senior Analyst) - Taiwan or Wuhan

Summary

Quality Control Microbiology Analyst (Senior Analyst)

Job Responsibilities

·         Perform routine analysis of environmental monitoring, in-process and finished formulations and/ or according to SOPs.

·         Participation in the JHL Environmental Monitoring Program to include system implementation, Facility Qualification, on-going monitoring (sampling, testing, trending).

·         Essential functions include but are not limited to: Bioburden Analysis, Endotoxin Analysis (Kinetic and Gel Clot), Viable and Non-Viable Air sampling and analysis, Surface and Personnel monitoring and analysis, Water Sampling and analysis (pH, Conductivity, Total Organic Carbon, and Nitrates).

·         Perform moderate data analysis and trending; document work according to GMP and notify management.

·         Perform routine equipment maintenance and calibration; maintain equipment logs according to GMP regulations.

·         May write and revise SOPs and provide feedback/peer review of procedures.

·         Work on a variety of problems of moderate scope.

·         Receive general instructions on routine work, detailed instructions on new assignments.

·         Propose and write modifications to SOPs; proactively initiate SOPs to ensure compliance. 

Job Qualifications (Education, Certifications, Experience)

·         Bachelor’s degree in a scientific discipline with 3+ years’ experience in quality control systems, or Master’s degree with 5+ years’ experience.

·         Working knowledge of GMP and ability to train others in the application of GMP.

·         Understanding of the basic statistics required in data analysis.

·         Thorough understanding of quality control systems.

·         Good overall understanding of the statistics required in relevant QC data analysis.

·         Ability to work effectively across departments regarding quality-control matters.

·         Demonstrated technical proficiency, scientific creativity, collaboration with others and independent thought.

·         Good working knowledge of scientific principles and manufacturing / regulatory principles.

·         Ability to synthesize information from disciplines outside primary field.

·         Demonstrated capability and ability to effectively plan for short term and long range needs.

·         Thorough knowledge of GMP regulations and documentation.

·         Strong computer system and database skills.

·         Ability to investigate and solve problems.

·         Ability to effectively communicate with personnel from multiple disciplines and experience bases across the operations organization.

·         Strong oral and written communication skills in English and Mandarin (Read, Write, Verbal) demonstrated by communicating with other functions and management regarding resolving investigations and theory, ability to write technical documents and statistical analysis of QC data.