Quality Lab Associate II – Sterility Assurance

This is whereyour work makes a difference.

At Baxter we believe every personregardless of who they are or where they are fromdeserves 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 jobyou will find purpose and pride.

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 highquality accurate and compliant documentation.

Within Quality every role makes a difference. Products that Baxter makes are shipped worldwide for patients in need. Whether its 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.

• 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

• 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 SMEs 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).

• Bachelors 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.

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 Baxterwe arecommitted toequitablepay for all employees and we strive to be moretransparentwith our pay practices. The estimated base salary for this position is $80000-$110000 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 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.

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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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