QC Microbiologist 1

MS0194 Medi-Physics, Inc.; Arlington Heights (IL); On-site; USD 48,000 - 71,000; Full time

Job summary

Medi-Physics, Inc. is seeking a Microbiologist I to perform in-process and release testing of injectable pharmaceutical finished products and raw materials.

The role includes environmental monitoring, microbiological identification, and support for validation studies in a global imaging agents company. The position requires a Bachelor’s in Microbiology or related field, aseptic technique expertise, and proficiency with Excel and MODA.

Qualifications

• Bachelor's degree in Microbiology or related science.
• Ability to work in ISO cleanrooms and follow GMP practices.
• Proficiency with Microsoft Excel.
• Legal authorization to work in the U.S.; visa sponsorship not provided.

Responsibilities

• Perform bioburden, sterility and bacterial endotoxin testing on final products and materials.
• Work aseptically in ISO-classified cleanrooms.
• Conduct environmental monitoring, growth promotion testing, and sample collection.
• Operate particle counters and data-entry tools such as Excel/MODA.
• Maintain accurate environmental and test records.
• Support validation projects and quality/compliance training.

Skills

Microbiology knowledge

Aseptic technique

Analytical skills

Attention to detail

Education

Bachelor's degree in Microbiology or related Science

Tools

Microsoft Excel

MODA

Job description

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 decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location.

In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI).

GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.

Additional Information GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation.

GE HealthCare is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law. GE HealthCare 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).

While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.

Relocation Assistance Provided: No

At GE HealthCare, we see possibilities through innovation. We’re partnering with our customers to fulfill healthcare’s greatest potential through groundbreaking medical technology, intelligent devices, and care solutions. Better tools enabling better patient care. Together, we are not only building a healthier future but living our purpose to create a world where healthcare has no limits.