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Quality Lab Associate I

https://www.baxter.com/ Logo

Baxter

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Location:
United States, Marion

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Category:
Quality Control

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Contract Type:
Employment contract

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Salary:

56000.00 - 77000.00 USD / Year

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
Job Link Share:

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