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Quality Manager I - Microbiology

Quality Manager I - Microbiology

BAXTERAsheville, NC, United States
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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 great results. You are motivated by work that is never the same from one day to the next. As a Quality Manager I, 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 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.

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 there's 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 you'll be doing

  • Develop a team of supervisors and / or department leads involved in microbiology testing of raw materials and finished good products.
  • Supervise product testing procedures for bioburden, microbial identification, endotoxin, and solution particulate matter.
  • Ensure compliance with Good Manufacturing Practice (GMP) and Good Laboratory Practice (GLP) and other relevant regulations and standards.
  • Coordinate with cross-functional teams to address testing requirements and timelines in support of change controls, protocols, and engineering studies.
  • Collaborate with Quality Assurance to achieve timely resolution of deviations, investigations, and corrective actions related to areas of responsibility.
  • Participate in internal and external audits, including direct interfacing with regulatory agencies such as FDA.
  • Remain informed about industry trends, regulatory changes, and emerging technologies related to microbiology testing.
  • Develop, maintain, and establish action plans as needed for Key Performance Indicators (KPIs) and Metrics to maintain and improve the efficiency and effectiveness of product testing processes.
  • Identify and lead continuous improvement projects with the objective of achieving quality, reliability and cost improvements.
  • Develops and ensures adherence to budget and reports on overspend as necessary to evaluate reason and possible corrections.
  • Manages the coaching, training and development process of subordinates.
  • Sustain a clean and safe work area using 6S principles.

What you'll bring

  • Bachelor's degree in Science, concentration in Biology or Microbiology, preferred.
  • Minimum 10 years' professional experience in Quality, Manufacturing, Engineering or related field.
  • Minimum 5 years' supervisory experience.
  • Knowledge of microbiology testing techniques, including bioburden, endotoxin, solution particulate matter detection, and microbial identification.
  • Familiarity with regulatory requirements including USP, FDA, and ISO standards.
  • Demonstration of leadership, communication, and interpersonal skills.
  • Strong analytical and problem-solving skills.
  • We understand compensation is an important factor as you consider the next step in your career. At Baxter,we arecommitted toequitablepay for all employees, and we strive to be moretransparentwith our pay practices. The estimated base salary for this position is $112,000 - $154,000 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.

    #LI-EB1

    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.

    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.

    By applying, you consent to your information being transmitted by College Recruiter to the Employer, as data controller, through the Employers data processor SonicJobs.

    See BAXTER Privacy Policy at privacy and SonicJobs Privacy Policy at us / privacy-policy and Terms of Use at us / terms-conditions

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