Quality Lab Associate I, Baxter

Quality Lab Associate I

Baxter

Location:

United States, Marion

Category:

Quality Control

Contract Type:

Employment contract

Salary:

56000.00 - 77000.00 USD / Year

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Job Description:

Conduct microbiological analysis, perform endotoxin and particulate matter testing, maintain laboratory equipment, assist with validations, and ensure compliance with cGMP, GLP, and FDA guidelines

Job Responsibility:

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

Requirements:

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

What we offer:

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
short-term and long-term disability insurance
Employee Assistance Program
childcare benefits

Additional Information:

Job Posted:

March 20, 2025

Employment Type:

Fulltime

Work Type:

On-site work

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