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General Electric Microbiologist in Arlington Heights, Illinois

Role Summary:The Quality Control Microbiologist is responsible for in-process and release testing of injectable pharmaceutical finished products. The role includes maintenance of controlled areas, environmental monitoring, analysis of results, raw material testing, growth promotion testing and performing microbiological identification techniques. The Microbiologist participates in the periodic review of procedures and supports validation studies as they pertain to microbiology.

Essential Responsibilities:• Perform required bioburden, sterility and bacterial endotoxin testing on final products and raw materials

• Perform viable and non-viable environmental monitoring

• Operate non-viable particle counter/facility monitoring systems

• Monitor sterility and environmental media for microbiological growth and perform incoming growth promotion testing

• Participates in validation projects requiring microbiology support

• Perform required procedures to initiate isolate identification from environmental samples and sterility tests

• Perform computer data entry with programs such as Microsoft Excel and MODA

• Maintain accurate records of environmental data and finished product/raw material testing

• Perform sanitation for testing hoods and enclosures and for the sterility room

• Perform sample collection and testing of the Reverse Osmosis system that feeds the production autoclaves; operate a TOC analyzer

• Collect data for periodic trending and annual review of test results

• Prepare supplies for sterilization (autoclave) and depyrogenation

• Perform requalification testing for gown and aseptic qualified operators

• Evaluate documentation and GMPs as they relate to microbiological issues

• Contribute to process improvement through Lean, 5S and six sigma tools

• Assist in the stocking and supplying of the QC Micro lab

• Understand maintenance and use of biological indicators

Qualifications/Requirements:1. Bachelor's degree in Microbiology or Biological degree or Associate's degree plus 2 years of working experience in Manufacturing or Laboratory

  1. Ability to speak, understand, read, and write in local language

  2. Proficient with software applications applicable to the job

  3. Must be available for early shifts and weekends as needed

  4. Must have the ability to distinguish color

  5. Ability to lift 25lbs

Quality Specific Goals:

  1. Knowledge and understanding of acceptance activity requirements for incoming, in-process, and final inspection requirements (as associated with job type/position) to ensure that product conforms to its specification and out of specification items are properly handled

  2. Knowledge and understanding of Shop Orders, Concessions, Calibration, Preventative Maintenance, Material Identification & Segregation, documentation configuration control practices; documentation & disposition of non-conforming material, Part 11 compliance and Good Documentation Practices requirements, as associated with this job type/position

  3. Aware of and comply with the GEHC Quality Manual, Quality Management System, Quality Management Policy, Quality Goals, and applicable laws and regulations as they apply to this job type/position

  4. Complete all planned Quality & Compliance training within the defined deadlines

  5. Identify and report any quality or compliance concerns and take immediate corrective action as required

Desired Characteristics:1. Aseptic Technique experience

  1. Microbiology Bachelor’s degree

  2. Cleanroom experience

  3. Microbial ID experience

  4. Experience with electronic data tracking systems such as MODA

  5. Sterility testing (membrane filtration, direct inoculation)

  6. Bioburden testing

  7. Attention to detail

About Us:GE (NYSE:GE) drives the world forward by tackling its biggest challenges. By combining world-class engineering with software and analytics, GE helps the world work more efficiently, reliably, and safely. GE people are global, diverse and dedicated, operating with the highest integrity and passion to fulfill GE’s mission and deliver for our customers. www.ge.com

GE offers a great work environment, professional development, challenging careers, and competitive compensation. GE is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, gender (including pregnancy), sexual orientation, gender identity or expression, age, disability, veteran status or any other characteristics protected by law.

Additional Eligibility Qualifications:GE will only employ those who are legally authorized to work in the United States for this opening. Any offer of employment is conditioned upon the successful completion of a drug screen (as applicable).Additional Locations:United States;Illinois;Arlington Heights;

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