Supervisor Quality Lab - Endotoxin

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. Youll feel a sense of purpose throughout the organization as we know our work improves outcomes for millions of patients.

Baxters 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.

Your Role at Baxter

This is where your creativity addresses challenges

You are creative thorough and a headsdown doer. You embrace a challenge and truly apply the collaborative powers of your team to produce great results. You are motivated by work that is never the same from one day to the next. As aQuality Lab SupervisorEndotoxin you are unafraid of navigating through necessary internal processes to facilitate a product you deeply believe in. You can absorb and act on complex procedures and data and train your team or peers if needed. You take pride in getting things done quickly without sacrificing safety or quality.

Your Team at Baxter

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 neverbeforeseen 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.

The Quality function values both working together as a team and independently. We draw energy from working in a plant or an office where there are opportunities to collaborate. As the company evolves so does the way our team approaches work as it strives to create topoftheline products.

We build relationships with each other to get work done. Building these relationships is easy because we all share common traits of being reliable ethical and caring. We lean on our colleagues for their expertise and hold each other accountable. We feel empowered to speak up when theres a new insight or opportunity to improve something. This open dialog builds trust within the team and helps create a better product for our customers.

What we offer from Day One:

• Shift flexibility to trade shifts and leverage overtime opportunities
• 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 youll be doing

• Prepare samples and perform endotoxin testing on raw materials solution and water for bioburden
• Perform particulate matter testing on solution
• Perform daily pH meter balance and pipette verification
• Administrator for Honeywell Automated Temperature Monitoring System
• Perform peptidoglycan and gel clot testing as needed
• Review calibration and daily lab check reports and approve testing
• Generate monthly trend reports
• Perform limit recalculations for trending purposes
• Conduct investigations for out of limit results
• Sterility testing for LAL
• Document Subject Matter Expert
• Act as a liaison between Endotoxin lab and Operations for batch release test scheduling to ensure customer commitments are met
• Calibration of micropipettes analytical balance water bath dry heat bath depyrogenation ovens light obscuration particle counters and spectrophotometer
• Responsible for daily lab upkeep including cleaning glassware washing and depyrogenation supply replenishment syringe and endotoxin prep
• Sustain a clean and safe work environment utilizing 6S principles
• Operate laboratory instrumentation and equipment such as laminar flow hoods micropipettors pH meters analytical balances and instruments used to perform particulate matter and endotoxin testing
• Write revise and approve Standard Operating Procedures and review jobrelated technical documents
• Participate and/or support internal/external and regulatory audits as needed
• Write exceptions nonconformance reports (NCRs) and CAPAs as needed utilizing TrackWise
• Train others on systems equipment procedures as needed
• Serve as mentor to other Quality Laboratory positions
• Assist in the development and of department initiatives and KPIs and effectively achieve team goals and expectations
• Assist in the development planning of direct reports
• Generate and execute protocols and method validations as needed
• Assist Investigators as needed with microbial out of limits investigations
• Act as a delegate for Quality Manager in their absence
• Ensure compliance with all applicable procedures/practices to include global and local SOPs safety USP ISO cGMP and applicable regulations

Knowledge Skills and Abilities

• Computer literate/knowledge of Microsoft office applications (Word Excel)
• Proficient in quality based computer systems such as LIMS POMS EndoscanV software Sampler Sight Pharma AS400 and TrackWise
• Attention to detail and able to manage multiple tasks/priorities in a timely manner
• Proficient in the operation of laboratory instrumentation and equipment such as laminar flow hoods micropipettors pH meters analytical balances and instruments used to perform particulate matter and endotoxin testing
• Good documentation skills and knowledge of GDPs (Good Documentation Practices)
• Knowledge of aseptic sampling and testing techniques and microbiological testing according to FDA cGMP GLPs and USP testing methodology
• Must be able to communicate effectively with all levels of the organization
• Must be experienced in executing general microbiology procedures
• Knowledge of aseptic technique and microbiological testing according to FDA cGMP GLPs and USP testing methodology
• Ability to create an environment that values people encourages trust teamwork and open communication through feedback and recognition

What youll bring

• Must be able to stand for extended periods

• Must be able to lift 50 lbs
• B.S. degree in Microbiology Biology or related science
• Minimum of 5 years of experience or Masters Degree in biological science with 14 years experience preferably in the pharmaceutical or medical device industry
• Prior supervisory experience preferred.

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 our employees and we strive to be more transparent with our pay practices. To that end this position has a base salary range of $80000 to $100000 plus an annual incentive bonus commission target and equity target. The above range represents the expected base salary range for this position. The actual salary may vary based upon several factors including but not limited to relevant skills/experience time in the role business line and geographic/office location.

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 wellbeing matters. Baxter offers comprehensive compensation and benefits packages for eligible roles. Our health and wellbeing benefits include medical and dental coverage that start on day one as well as insurance coverage for basic life accident shortterm and longterm 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 timeoff 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.

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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