Quality Lab Associate I - Endotoxin (7:00pm-7:00am)

Baxter International; Marion (NC); On-site; USD 50,000 - 80,000; Full time

Job summary

An established industry player is seeking a dedicated microbiologist to join their Quality team. In this role, you will conduct vital microbiological analyses, ensuring the highest standards of quality for life-saving products. Your expertise will help maintain a clean and safe laboratory environment while managing testing protocols and training new team members. This is a fantastic opportunity to contribute to a mission-driven organization that prioritizes patient outcomes and innovation in healthcare. If you are passionate about science and making a difference, this position is perfect for you.

Qualifications

• 2-5 years of experience in microbiology or a related field.
• Knowledge of FDA, cGMP, GLPs, and USP testing methodology.

Responsibilities

• Conduct microbiological analysis on raw materials and water samples.
• Perform endotoxin testing and manage reagent inventory.
• Train others in microbiological testing and maintain lab equipment.

Skills

Microbiology procedures

Attention to detail

Documentation skills

Communication skills

Education

B.S. degree in Microbiology

Master’s Degree in biological sciences

Tools

LIMS

POMS

Endoscan-V software

Sampler Sight Pharma

AS400

Laboratory instrumentation

Job description

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission.

Your Role at Baxter

This is where your creativity addresses challenges

Conduct microbiological analysis on raw materials, solution, and water samples following approved Standard Operating Procedures in an accurate and timely manner.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

What you'll be doing

• Prepare samples and perform endotoxin testing on raw materials, solution, and water for bioburden
• Perform particulate matter testing on solution
• Perform daily pH meter, balance, and pipette verification
• Perform daily Honeywell automated temperature checks and manual temperature monitoring
• Perform peptidoglycan and gel clot testing as needed
• Manage reagent inventory
• Generate monthly trend reports
• Calibration of micro-pipettes, analytical balance, water bath, dry heat bath, depyrogenation ovens, light obscuration particle counters and spectrophotometer
• Responsible for daily lab upkeep including cleaning, glassware washing and depyrogenation, supply replenishment, syringe and endotoxin prep
• Assist in method validation and protocol testing as needed
• Sustain a clean and safe work environment utilizing 6S principles
• Operate laboratory instrumentation and equipment such as laminar flow hoods, micro-pipettors, pH meters, analytical balances, and instruments used to perform particulate matter and endotoxin testing
• Write and revise Standard Operating Procedures and review job-related technical documents
• Perform laboratory and manufacturing audits as required
• Train others to perform microbiological testing/tasks
• Serve as mentor to Quality Lab Associate I (QLA I) positions
• Serve as a back-up to Quality Lab Associate III (QLA III) in their absence
• Write exceptions, nonconformance reports (NCRs) and CAPAs as needed utilizing TrackWise

What you'll bring

• B.S. degree in Microbiology, Biology, or related science
• 2-5 years of experience or Master’s Degree in biological sciences with 0-3 years experience, preferably in the pharmaceutical or medical device industry
• Computer literate/knowledge of Microsoft office applications (Word, Excel)
• Proficient in quality based computer systems such as LIMS, POMS, Endoscan-V software, Sampler Sight Pharma, and AS400
• Attention to detail and ability to prioritize multiple tasks
• Proficient in the operation of laboratory instrumentation and equipment such as laminar flow hoods, micro-pipettors, pH meters, analytical balances, and instruments used to perform particulate matter and endotoxin testing
• Good documentation skills and knowledge of GDPs (Good Documentation Practices)
• Knowledge of aseptic sampling and testing techniques and microbiological testing according to FDA, cGMP, GLPs and USP testing methodology
• Must be able to communicate effectively with supervisors and peers
• Must be experienced in executing general microbiology procedures
• Must be able to stand for extended periods
• Must be able to lift 50 lbs

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.