Quality Lab Associate II

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

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.
• Understanding of laboratory investigation processes.
• Familiarity with data integrity principles (ALCOA+).
• Knowledge of aseptic technique and contamination-control practices.
• Strong troubleshooting and problem-solving skills.
• Ability to interpret laboratory data and identify trends.
• Strong written and verbal communication skills.
• Ability to manage multiple priorities in a fast-paced environment.
• Proficiency with laboratory software systems and Microsoft Office applications.

Physical Requirements

• Ability to stand and walk for extended periods.
• Ability to perform repetitive laboratory tasks requiring fine motor skills.
• Ability to lift up to 25 pounds.
• Ability to work while wearing laboratory PPE.
• Ability to distinguish colors and observe small details during testing and inspections.

Preferred Competencies

• Analytical chemistry expertise.
• Microbiological laboratory techniques.
• Technical writing and documentation.
• Root cause investigation support.
• Statistical analysis and data trending.
• Continuous improvement mindset.
• Strong attention to detail and data accuracy.

Key Performance Indicators

• On-time completion of laboratory testing.
• Right-first-time data generation.
• Documentation accuracy and compliance.
• Investigation support effectiveness.
• Laboratory audit readiness.
• Instrument uptime and maintenance compliance.
• Environmental monitoring and utility testing compliance.
• Adherence to safety, quality, and regulatory requirements.

Career Progression

This role serves as an experienced laboratory analyst position and may provide advancement opportunities into:

• Quality Laboratory Associate III
• Quality Control Specialist
• Laboratory Supervisor
• Microbiology Lead
• Analytical Laboratory Lead
• Quality Systems Specialist
• Validation Specialis

Pay and benefits

We understand compensation is an important factor as you consider the next step in your career. At Baxter, we are committed to equitable pay for all employees, and we strive to be more transparent with our pay practices. The estimated base salary for this position is $80,000 - $110,000 annually. The estimated range is meant to reflect an anticipated salary range for the position.

We may pay more or less than of the anticipated range based upon market data and other factors, all of which are subject to change. Individual pay is based on upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

For questions about this, our pay philosophy, and available benefits, please speak to the recruiter if you decide to apply and are selected for an interview.

Applicants must be authorized to work for any employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

Benefits

US Benefits at Baxter (except for Puerto Rico):

This is where your well-being matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and well-being benefits include medical and dental coverage that start on day one, as well as insurance coverage for basic life, accident, short-term and long-term disability, and business travel accident insurance.

Financial and retirement benefits include the Employee Stock Purchase Plan (ESPP), with the ability to purchase company stock at a discount, and the 401(k) Retirement Savings Plan (RSP), with options for employee contributions and company matching.

We also offer Flexible Spending Accounts, educational assistance programs, and time-off benefits such as paid holidays, paid time off ranging from 20 to 35 days based on length of service, family and medical leaves of absence, and paid parental leave. Additional benefits include commuting benefits, the Employee Discount Program, the Employee Assistance Program (EAP), and childcare benefits.

Join us and enjoy the competitive compensation and benefits we offer to our employees. For additional information regarding Baxter US Benefits, please speak with your recruiter or visit our Benefits site: Benefits | Baxter