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Quality Lab Associate III - Validation Analytics

Quality Lab Associate III - Validation Analytics

BaxterAsheville, NC, United States
12 hours ago
Job type
  • Full-time
Job description

This is where your 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.

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 Lab Associate III, 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.

Your role at Baxter :

Responsible for performance and efficiency of Analytical Validation and Qualification activities. Lead and / or coordinate activities in support of analytical validation operations to ensure safe operations, effective planning, and regulatory compliance in the performance of method, process, cleaning, and stability validations for various chemical products while maintaining high standards for quality and responsiveness to production requirements.

What you'll be doing :

  • Create validation packages for computer systems, processes, cleaning procedures, analytical methods, and laboratory equipment to demonstrate a validated state of control.
  • Write protocols, manage the execution of validation testing plans by liaising with other department to coordinate validation activities, compile and analyze data, and prepare validation packages
  • Coordinate IQ / OQ / PQ activities with Production, Quality Control Laboratories, outside contractors, corporate engineering, and other validation groups.
  • Responsible to be a subject matter expert for lab equipment, practices, and methods as they pertain to execution of special testing protocols and validations.
  • Monitor and support the execution of the protocols through training, facilitating, and problem-solving activities.
  • Provide guidance and assistance on validation formats, requirements, and procedures as a team member on various protocol projects.
  • Support training for team members and provide resource information as a technical expert.
  • Review completed protocols and testing packages for compliance with quality and regulatory requirements.
  • Support / participate in the mixing, flush and cleaning validation programs.
  • Contribute / participate in facility Quality review meetings.
  • Participate as the Validation SME during regulatory and corporate compliance inspections.
  • Participate in quality assessments of internal operations and suppliers, to analyze compliance and assess risk.
  • Write, revise and approve Standard Operating Procedures
  • Sustain a clean and safe work environment applying 6S principles

What you'll bring :

  • B.S. degree in Natural Sciences : Chemistry, Microbiology, Pharmacy, Computer Science, or Engineering preferred
  • Minimum of 5 years of experience or Masters / Ph.D. degree in Natural Sciences with 1-3 years experience in a GMP Laboratory, preferably in the pharmaceutical or medical device industry
  • Intermediate to Advanced proficiency of Microsoft office applications (Word, Excel, PowerPoint)
  • Attention to detail and strong organizational skills
  • Strong analytical and problem-solving skills and critical thinking abilities.
  • Must have a strong understanding of laboratory instrumentation
  • Good documentation skills and knowledge of GDPs (Good Documentation Practices)
  • Strong ability to manage multiple tasks / priorities in a timely manner
  • Working knowledge of TrackWise system
  • Strong written and oral communications skills, negotiation skills, and ability to work with all levels of the organization.
  • Role models personal accountability for results and integrity and relentless focus on rapid and disciplined action
  • 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 $80,000-$110,000 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.

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