Quality Lab Associate III - Sterility Assurance

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You'll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.

Baxter's products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.

Join us at the intersection of saving and sustaining lives- where your purpose accelerates our mission.

This is where your creativity addresses challenges

The role of Quality Laboratory Associate III (QLAIII) - Sterility Assurance is primarily responsible for executing routine activities and continuous improvement projects which promote contamination control of the cleanroom manufacturing facility and processes. This position may be an independent contributor role or may have 1 - 4 direct reports.

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.

• 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

• Lead continuous improvement projects to implement best practices as it relates to contamination control design and processes throughout the manufacturing facility
• Through continuous improvement efforts, work to streamline and improve cleaning procedures across multiple operating lines and areas through evidence-based support
• Write, review, and/or approve environmental cleaning protocols to support cleaning practices
• Coordinate completion of environmental cleaning efficacy studies
• Define, supervise and improve training program(s) for clean room behavior and contamination control practices
• Lead classroom-based trainings for new employees and continuous education classes for established employees of various backgrounds
• Support ongoing projects throughout the facility by:
• Directing a team in the completion of environmental FMEAs
• Assessing potential environmental impact of a proposed change to facility or processes
• Contributing to craft of projects considering most recent standards from Annex I, ISO14644-1, and other documents
• Performing risk assessments for construction-based activities, including establishing project specific control plans such as containment measures, debris removal, and pest control
• Coordinate responses to environmental and process conditions detected during Real Time Risk Assessments (RTRA)
• Collaborate with microbial investigators and manufacturing compliance teams to determine potential CAPA items in response to microbial out of limits
• Establish appropriate response plans to environmental events during manufacturing
• Author and revise relevant Standard Operating Procedures to support continuous improvement projects, CAPAs, and periodic reviews
• Lead and participate in the investigation of microbiological events and cleaning deviations through nonconformance system in TrackWise
• Act as Subject Matter Expert (SME) for the above responsibilities during regulatory inspections, including interfacing with regulatory authorities on site
• Sustain a clean and safe work area using 6S principles
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

• B.S. degree in Microbiology, Biology, or related science
• 0-2 years of experience; minimum 1-year experience in Pharmaceutical/Medical Device industry preferred
• Must be at least 18 years of age
• Extensive knowledge in aseptic technique, cleanroom behavior and practice, and cleaning methodologies and risk assessments
• Strong communication and project management skills
• Must have detailed understanding of pharmaceutical/medical device manufacturing and current Good Manufacturing Practices and Good Documentation Practices
• Must have good analysis, troubleshooting, and investigation skills including knowledge and understanding of problem-solving methodologies (e.g. DMAIC, Fishbone Diagram)
• Must have strong technical writing skills and able to put sophisticated thoughts and issues into writing in such a manner that can be understood by the reader
• Must be able to get along with, and influence others at various levels in multiple departments
• Must have knowledge of FDA quality systems regulations, preferably experience interacting with FDA or similar regulatory agencies
• Understand verbal and written safety and quality instructions and read and comprehend written work instructions including words and drawings.
• Must have basic English written and oral communication skills adequate to connect with other team members

We understand compensation is a meaningful 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 clear with our pay practices. The estimated base salary for this position is $76,000 - $104,500 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.

EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy

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.

Recruitment Fraud Notice

Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice.