Quality Lab Associate II – Sterility Assurance

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. Our colleagues are united by our Mission to Save and Sustain Lives. Together, we are driven by a culture of courage, trust, and collaboration, where every individual is empowered to take ownership and make a meaningful impact.

About the role

The Quality Laboratory Associate II – Sterility Assurance is responsible for authoring, revising, and maintaining microbiology and sterility assurance GMP documentation, ensuring alignment with regulatory expectations, site practices, and global quality standards. This role supports contamination control, investigation readiness, inspection preparedness, and consistent laboratory execution through high-quality, accurate, and compliant documentation.

Responsibilities

• Author, revise, and maintain microbiology and sterility assurance documentation, including:
  • Standard Operating Procedures (SOPs)
  • Work Instructions
  • Protocols and reports (EMPQ, validation, qualification)
  • Forms, templates, and controlled records
• Evaluate existing documentation and determine appropriate revisions to ensure alignment with current processes, regulatory requirements, and quality system expectations.
• Interpret complex microbiology, contamination control, and laboratory practices and translate them into clear, accurate, compliant, and executable documentation.
• Collaborate with subject matter experts (SMEs) in Bioburden, Environmental Monitoring, Identification, Lysate, Particulate Matter, Investigations, and Sterility Assurance to assess documentation needs and recommend improvements that enhance compliance, efficiency, and laboratory execution.
• Determine appropriate documentation strategies to support contamination control initiatives, inspection readiness, and operational consistency.
• Ensure documentation aligns with cGMP, GDP, FDA, USP, ISO, and internal quality system requirements, as well as site-specific contamination control strategies.
• Review and approve document changes within assigned authority levels, ensuring accuracy, consistency, and regulatory compliance.
• Support change control activities by evaluating the impact of proposed changes and coordinating documentation updates related to CAPAs, investigations, continuous improvement initiatives, process or facility changes.
• Prioritize documentation activities based on business needs, compliance risk, investigation outcomes, and site objectives.
• Participate in cross-functional project teams and provide recommendations that support laboratory improvements, simplification efforts, and deviation reduction initiatives.
• Conduct independent reviews of microbiology documentation and determine document readiness for implementation, audit support, and regulatory inspection.
• Identify documentation gaps, compliance risks, and process vulnerabilities and make recommendations to mitigate potential execution errors or deviations.
• Support audits and inspections by preparing documentation packages, leading or supporting document walkthroughs, and providing documentation expertise during regulatory interactions.
• Establish and maintain document version control, consistency standards, and archival compliance requirements.
• Make recommendations to simplify, standardize, and improve documentation systems and practices to enhance effectiveness and reduce rework.
• Exercise sound judgment in resolving documentation issues, prioritizing competing requests, and escalating compliance concerns as appropriate.
• Sustain a clean and safe work environment utilizing 6S principles.
• Learn, understand, and apply rigorous quality standards, SOPs, and Current Good Manufacturing Practices (cGMP).

Requirements

• Bachelor’s degree in Microbiology, Biology, Chemistry, Technical Writing, or related scientific discipline required.
• 5 or more years’ experience in a regulated pharmaceutical, medical device, or biologics environment.
• Previous experience writing or managing microbiology, sterility assurance, or manufacturing quality documentation strongly preferred.
• Experience with change management and document control systems required.
• Working knowledge of GMP documentation principles, regulatory expectations, and quality system requirements.
• Understanding of microbiology, contamination control, and laboratory quality systems.
• Demonstrated ability to work independently and make informed decisions with minimal supervision.
• Ability to evaluate documentation risks, determine appropriate corrective actions, and recommend sustainable solutions.
• Professional judgment in managing controlled documentation, interpreting regulatory requirements, and determining appropriate content revisions.
• Ability to influence SMEs and stakeholders to ensure accurate content ownership, timely reviews, and effective decision-making.
• Strong analytical and problem-solving skills with the ability to assess competing priorities and make risk-based decisions.
• Ability to identify compliance concerns and determine when escalation or additional review is required.
• Ability to meet deadlines in a fast-paced, regulated environment while balancing quality, compliance, and business priorities.

Benefits

• Medical, dental, and vision coverage starting on day one
• 160 hours of paid time off and paid holidays
• 401K match
• Employee Stock Purchase Plan
• Paid parental leave
• Tuition reimbursement
• Flexible Spending Accounts
• Educational assistance programs
• Paid holidays, paid time off (20–35 days based on length of service), family and medical leaves of absence, and paid parental leave
• Commuting benefits
• Employee Discount Program
• Employee Assistance Program (EAP)
• Childcare benefits

Pay

The estimated base salary for this position is $80,000–$110,000 annually. The range reflects an anticipated salary range based on market data and other factors, including location, skills, expertise, and experience. This position may also be eligible for discretionary bonuses.