Quality Lab Supervisor - Bioburden

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 heads-down do-er. You embrace a challenge and truly apply the collaborative powers of your team to produce phenomenal results. You are motivated by work that is never the same from one day to the next. As aQuality Lab Supervisor -Bioburden you are unafraid of navigating through vital internal processes to facilitate a product you deeply believe in. You can absorb and act on sophisticated 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 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.

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 top-of-the-line 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

Essential Duties and Responsibilities:

• Supervise and coordinate activities of the bioburden laboratory team.
• Facilitate hiring coaching performance and development process of bioburden testing team members.
• Ensure proper execution of solution bioburden testing water testing and other microbial assays per USP EP and internal procedures.
• Review and approve test results laboratory documentation and deviations in compliance with cGMP GLP and company SOPs.
• Maintain and troubleshoot laboratory instruments and ensure calibration and preventive maintenance are performed.
• Train mentor and evaluate lab personnel on techniques documentation practices and safety procedures.
• Participate in out-of-specification (OOS) investigations CAPAs and change controls.
• Develop and revise SOPs testing protocols and validation documentation.
• Monitor lab compliance with data integrity and regulatory guidelines (FDA EMA etc.).
• Support audits and regulatory inspections as an SME for solution bioburden testing.
• Oversee inventory and ordering of laboratory supplies.

Qualifications:

• Bachelors or Masters degree in Microbiology Pharmaceutical Sciences Biology or related field.
• 2-5 years of experience in a cGMP pharmaceutical microbiology lab with at least 2 years of experience with bioburden testing.
• Strong knowledge of bioburden testing microbial limits water systems and aseptic techniques.
• Experience with regulatory audits (FDA EMA etc.) and quality systems.
• Proficient in laboratory software and data integrity principles.
• Excellent communication leadership and organizational skills.

Applicants must be authorized to work for an employer in the U.S. We are unable to sponsor or take over sponsorship of an employment visa at this time.

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 $88000 - $121 000 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. 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.

Other Duties as Assigned

Please note 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.

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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.

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.

Recruitment Fraud Notice

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