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Associate III, Quality

Associate III, Quality

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

Quality Manager

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.

What You Will Be Doing

  • Consider safety of themselves and others as first and foremost.
  • Manage, oversee, track and drive accountability of all active projects in Cell 2 Quality.
  • Interact with other global Baxter facility representatives (IPSO customers) that North Cove (Cell 2) supplies product to when quality issues arise. Work with Cell 2 Manufacturing to resolve these quality issues between other global Baxter facilities and North Cove in a collaborative way.
  • Own, coordinate or lead multiple projects consecutively while performing other required job duties. Work with corporate teams when needed.
  • Manage / oversee the department monthly and quarterly trends. Make improvements to trending as needs and requirements change.
  • Become a resident SME of plastics areas. Serve as Subject Matter Expert (SME) by maintaining a high level of expertise in current regulatory requirements. Provide training and coaching to local employees and others as needed in relevant area(s). When required, assist other Quality areas in the successful performance of these activities.
  • Perform the duties of the Cell 2 Quality Manager when needed. Run the Cell 2 Quality department on a daily basis when the manager is not available.
  • Cover the daily tasks and exceptions as they happen on the floor and oversee QT's when floor QA is out.
  • Other duties, tasks or projects as assigned.

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 preferred.
  • Strong communication and interpersonal skills and great attention to detail are necessary.
  • Strong project management skills are necessary.
  • Possess a working knowledge of FDA Regulations and Application of Good Manufacturing Practices (cGMP) and Good Documentation Practices.
  • Must have knowledge of FDA quality systems regulations, preferably experience interacting with FDA or similar regulatory agencies.
  • Must have good analysis, troubleshooting, and investigation skills including knowledge and understanding of problem-solving methodologies (e.g. DMAIC, Fishbone Diagram).
  • Write, review, and revise Standard Operating Procedure (SOP) and process changes when necessary and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
  • 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 $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.

    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.

    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.

    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 let us know the nature of your request along with your contact information.

    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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