Quality Lab Associate II

Baxter International Inc. • Marion, NC

1d • $80,000 - $110,000

About The Position

The Quality Laboratory Associate II performs routine and non-routine analytical, chemical, and microbiological testing of raw materials, in-process samples, utilities, environmental monitoring samples, and finished pharmaceutical products. The role 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. The position requires strong technical laboratory skills, attention to detail, and the ability to work effectively in a regulated pharmaceutical environment.

Requirements

• 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.
• 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.
• 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.

Nice To Haves

• 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.
• 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.

Responsibilities

• Perform routine and non-routine analytical testing using approved laboratory methods.
• Conduct chemical analysis of raw materials, intermediates, bulk product, and finished product samples.
• Use laboratory instrumentation including HPLC, UPLC, GC, UV-Visible spectroscopy, FTIR, pH meters, conductivity meters, osmometers, and TOC analyzers.
• Execute assay, identification, impurity, and physical characteristic testing, and perform method suitability and system suitability evaluations.
• Review analytical data for accuracy, completeness, and compliance.
• Perform microbiological testing of pharmaceutical products, utilities, and environmental monitoring samples.
• Conduct microbial identification and enumeration testing, bioburden testing, and microbial recovery studies.
• Perform environmental monitoring, including air sampling, surface sampling, and 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.
• Prepare reagents, standards, media, and laboratory solutions.
• Maintain laboratory notebooks, worksheets, logbooks, and electronic records, and review documentation for completeness and compliance with Good Documentation Practices.
• Support sample receipt, storage, tracking, and disposal activities; maintain laboratory inventory and consumable supplies.
• Keep laboratory work areas clean, organized, and inspection ready.
• Perform routine calibration, verification, and maintenance of laboratory equipment; troubleshoot instrumentation and coordinate repairs when necessary.
• Assist with instrument qualification and validation, and support laboratory computer systems and data integrity requirements.
• Investigate OOS, 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.

Benefits

• Medical coverage starting on day one
• Dental coverage starting on day one
• Basic life insurance
• Accident insurance
• Short-term disability insurance
• Long-term disability insurance
• Business travel accident insurance
• Employee Stock Purchase Plan (ESPP) with ability to purchase company stock at a discount
• 401(k) Retirement Savings Plan with employee contributions and company matching
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays
• Paid time off ranging from 20 to 35 days based on length of service
• Family and medical leaves of absence
• Paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits
• Potential eligibility for discretionary bonuses

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level