QC Microbiologist 1

GE HealthCare; Arlington Heights (IL); Sur place; USD 48 000 - 71 000; Plein temps

Résumé du poste

GE HealthCare in Arlington Heights, IL is seeking a Microbiologist to perform in-process and release testing of injectable products, maintain controlled areas, and conduct environmental monitoring. The role supports validation work and requires attention to GMP practices.

The successful candidate will hold a Bachelor’s degree in Microbiology or related science, be proficient with Microsoft Office, and be able to work early shifts, weekends, and holidays as needed. VISA sponsorship is not offered.

Qualifications

• Bachelor's degree in Microbiology or related Science degree.
• Ability to speak, understand, read and write in English.
• Proficiency with Microsoft Office Suite (including Excel and Access).
• Availability for early shifts, weekends, and holidays as needed.

Responsabilités

• Perform key bioburden, sterility and endotoxin testing on finished products and materials.
• Work aseptically in ISO class cleanrooms and monitor environmental conditions.
• Conduct environmental monitoring and growth promotion testing as required.
• Maintain accurate documentation and enter data using Excel and MODA.
• Support microbiology validations and participate in process improvements.

Connaissances

Microbiology techniques

Sterile/aseptic technique

Environmental monitoring

Growth promotion testing

Data entry and analysis (Excel)

Formation

Bachelor's degree in Microbiology or related Science degree

Outils

MODA

Microsoft Excel

Microsoft Access

Description du poste

Job Description Summary

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

Our Pharmaceutical Diagnostics (PDx) business is a global leader in imaging agents, used to improve and enhance the images that radiologists use to diagnose and monitor disease. We support healthcare professionals in the administration of neurology, cardiology and oncology procedures that are used to image three patients around the world, every second.

Job Description

Key responsibilities/essential functions include:

• Perform required bioburden, sterility and bacterial endotoxin testing on final products and raw materials utilizing specialized equipment
• Work aseptically in sterile manufacturing and testing ISO classified cleanrooms
• 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
• Participate 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 sample collection and testing of the Reverse Osmosis system that feeds the production autoclaves; operate a Total Organic Carbon analyzer
• Prepare supplies for sterilization (autoclave) and depyrogenation (dry heat oven)
• 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
• Understand maintenance and use of biological indicators
• Create/perform unscheduled work orders and preventative maintenance records for laboratory upkeep

Quality Specific Goals:

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

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

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

Complete all planned Quality & Compliance training within the defined deadlines

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

Required Qualifications:

• Required Schedule: Monday - Friday, 6:00 AM - 2:30 PM
• Bachelor's degree in Microbiology or related Science degree
• Ability to speak, understand, read and write in local language
• Proficiency with Microsoft Office Suite (including Access)
• Availability for early shifts, weekends, and holidays as needed
• Ability to distinguish color
• Knowledge of microbiological techniques (gram stain/microbial ID, aseptic, gowning, etc.)
• Ability to lift 25lbs
• Legal authorization to work in the U.S. is required. We will not sponsor individuals for employment visas, now or in the future, for this job opening.

Preferred Qualifications:

• Cleanroom experience
• Experience with electronic data tracking systems such as MODA
• Experience with bioburden, sterility and bacterial endotoxin testing

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership -always with unyielding integrity.

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you'd expect from an organization with global strength and scale, and you'll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

We will not sponsor individuals for employment visas, now or in the future, for this job opening.

For U.S. based positions only, the pay range for this position is $47,600.00-$71,400.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation