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Associate III, Quality

Associate III, Quality

BaxterMarion, NC, United States
30+ days ago
Job type
  • Full-time
Job description

This is where your work makes a difference.

At Baxter, we believe every person-regardless of who they are or where they are from-deserves 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 job-you will find purpose and pride.

Successfully perform all the primary activities as defined in the QA I and QA II job positions. Handle multiple projects. Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, problem solving and team leadership. Lead and / or participate in Kaizen or equivalent focus type group activities. Design, lead and perform experiments using sound scientific principles. A functional understanding of FDA, ISO and Baxter Quality systems is also required.

What you will do

  • Learn, understand, review and apply Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)
  • Perform and / or verify correction and containment activities and review documentation of these activities when process anomalies occur (EMW and NCR).
  • When required, assist other Quality areas by leading departmental activities including supervision of assigned personnel.
  • Be directly involved in, and where appropriate, lead multiple process / product improvement projects which may include Kaizen, or other focus groups, design of experiments, validations, development of new methodologies and improving existing methodologies, data generation, report development and presentation.
  • Maintain a high level of expertise in current regulatory requirements, and serve as a plant resource for compliance to these requirements
  • Lead in the development of customer awareness and understanding activities for areas of direct responsibility, and where appropriate, assist and support such activities throughout the facility.
  • Provide guidance and coaching for the areas of responsibility for less experienced individuals within the plant.
  • Must be a recognized by all levels of the facility as an expert in their area and be able to demonstrate leadership ability.
  • Must have the ability to perform the responsibilities of the Quality Section Manager on an as needed basis.
  • Assists and reviews validations for equipment, product changes and computer systems.
  • Assists with and reviews vendor audits / assessments and provides ongoing feedback related to quality issues.
  • Sustain a clean and safe work area using 6S principles

What do you bring

  • Bachelor's degree in science or engineering required. Advanced degree in the life sciences, physical sciences or engineering preferred.
  • Minimum of 5 years of quality experience in pharma, medical device or related field
  • Understand scientific strategies and be able to invent new methods or new avenues of investigation.
  • Understanding of Label Copy Control, as well as, change control processes.
  • Good interpersonal / communication / influencing / negation skills.
  • Good project management skills
  • Working knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
  • 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 communicate 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 $88,000 - $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. 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.

    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.

    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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