Quality Lab Associate I - Endotoxin
Baxter International Inc.About the role
This is where your work makes a difference.
At Baxter, we believe every person—regardless of who they are or where they are from—deserves a chance to live a healthy life. It was our founding belief in 1931 and continues to be our guiding principle. We are redefining healthcare delivery to make a greater impact today, tomorrow, and beyond.
Our Baxter colleagues are united by our Mission to Save and Sustain Lives. Together, our community is driven by a culture of courage, trust, and collaboration. Every individual is empowered to take ownership and make a meaningful impact. We strive for efficient and effective operations, and we hold each other accountable for delivering exceptional results.
Here, you will find more than just a job—you will find purpose and pride.
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 we offer from Day One
Medical, Dental and Vision coverage
160 hours of Paid Time Off and Paid Holidays
401K match
Employee Stock Purchase Program
Paid Parental Leave
Tuition Reimbursement
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
Minimum 2 years of experience or Master’s Degree in biological sciences with relevant 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 e
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