Quality Lab Associate II

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

The Quality Laboratory Associate II is responsible for performing routine and non-routine analytical, chemical, and microbiological testing of raw materials, in-process samples, utilities, environmental monitoring samples, and finished pharmaceutical products. The position supports product release, stability programs, investigations, process validation activities, and continuous quality monitoring while ensuring compliance with cGMP, regulatory requirements, and site procedures.

The Associate II independently executes laboratory testing, evaluates data for accuracy and compliance, maintains laboratory instrumentation, and supports laboratory investigations. This role requires strong technical laboratory skills, attention to detail, and the ability to work effectively in a regulated pharmaceutical environment.

What you'll be doing

Analytical and Chemical Testing

• Perform routine and non-routine analytical testing using approved laboratory methods.
• Conduct chemical analysis of raw materials, intermediates, bulk product, and finished product samples.
• Perform testing using laboratory instrumentation including: High Performance Liquid Chromatography (HPLC) Ultra Performance Liquid Chromatography (UPLC) Gas Chromatography (GC) UV-Visible Spectroscopy Fourier Transform Infrared Spectroscopy (FTIR) pH meters Conductivity meters Osmometers Total Organic Carbon (TOC) analyzers
• Execute assay, identification, impurity, and physical characteristic testing.
• Perform method suitability and system suitability evaluations.
• Review analytical data for accuracy, completeness, and compliance.

Microbiological Testing

• Perform microbiological testing of pharmaceutical products, utilities, and environmental monitoring samples.
• Conduct microbial identification and enumeration testing.
• Perform bioburden testing and microbial recovery studies.
• Execute environmental monitoring activities, including: Air sampling Surface sampling Personnel monitoring
• Support water system monitoring and utility testing programs.
• Perform endotoxin testing using approved methodologies.
• Conduct growth promotion and media qualification studies.
• Interpret microbiological results and escalate atypical findings.

Laboratory Operations

• Prepare reagents, standards, media, and laboratory solutions.
• Maintain laboratory notebooks, worksheets, logbooks, and electronic records.
• Review laboratory documentation for completeness and compliance with Good Documentation Practices.
• Support sample receipt, storage, tracking, and disposal activities.
• Maintain laboratory inventory and consumable supplies.
• Ensure laboratory work areas remain clean, organized, and inspection ready.

Equipment and Instrumentation

• Perform routine calibration, verification, and maintenance activities on laboratory equipment.
• Troubleshoot laboratory instrumentation and coordinate repairs when necessary.
• Assist in instrument qualification and validation activities.
• Support laboratory computer systems and data integrity requirements.

Quality Systems Support

• Investigate out-of-specification (OOS), out-of-trend (OOT), and atypical results.
• Participate in deviation investigations, CAPAs, change controls, and laboratory investigations.
• Support method validation, method transfer, and verification studies.
• Assist with process validation, cleaning validation, and product stability programs.
• Participate in internal audits, regulatory inspections, and customer audits.
• Ensure compliance with cGMP, FDA, EMA, USP, and internal quality requirements.

What you'll bring

Required

• Bachelor's degree in Chemistry, Microbiology, Biology, Biochemistry, Pharmaceutical Sciences, or a related scientific discipline.
• Minimum 2 years of laboratory experience in a regulated pharmaceutical, biotechnology, medical device, or related industry.

Preferred

• Advanced coursework in analytical chemistry, microbiology, or pharmaceutical sciences.
• Experience working within a cGMP laboratory environment.
• Experience with both chemical and microbiological testing.
• Experience supporting pharmaceutical manufacturing operations.

Knowledge, Skills, and Abilities

• Knowledge of cGMP regulations and quality system requirements.
• Working knowledge of USP compendial testing requirements.

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