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. 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

This is where your creativity addresses challenges

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.

Your Team at Baxter

Within Quality, every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether it's building a new process from scratch or facing a never-before-seen production hurdle, individuals within Quality are given the trust and opportunity to bring creativity to the table. Regardless of your specific role with a product, it is sure to touch a portion of our global operation.

The mission of Baxter is to save and sustain lives. This mission is embedded into everything we do. This means if there is a decision to be made where quantity and quality are at odds, we will always choose quality. Our patients come first, always.

What we offer from Day One

• 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

What you'll be doing

• 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 the following SME’s to assess documentation needs and recommend improvements that enhance compliance, efficiency, and laboratory execution: Bioburden, Environmental Monitoring, Identification, Lysate, Particulate Matter, Investigations, Sterility Assurance.
• 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, 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, 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).

What you'll bring

• 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.

Other Duties as Assigned

This job description is not designed to cover or contain a comprehensive listing of activities, duties, or responsibilities that are required of the employee for this job. Duties, responsibilities, and activities may change at any time with or without notice. Overtime is worked as required.

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.

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

Equal Employment Opportunity

Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

Know Your Rights: Workplace Discrimination is Illegal

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.

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