Associate I, Quality

Baxter International; Marion (NC); On-site; USD 68,000 - 94,000; Full time

Benefits offered by this job

Medical, Dental and Vision coverage

160 hours of Paid Time Off and Paid H…

401K match

Employee Stock Purchase Program

Paid Parental Leave

Tuition Reimbursement

Job summary

Baxter in Marion, NC is seeking a Quality professional to provide oversight and support across quality processes. You will identify regulatory and quality risks, lead daily operations, supervise staff, and develop corrective actions to ensure patient safety and compliance.

The role requires a bachelor's degree in engineering or science, strong interpersonal and communication skills, and the ability to manage multiple projects.

Qualifications

• Bachelor's degree strongly preferred; engineering or science background.
• Must be 18+ years old with high school diploma or GED.
• Strong interpersonal skills and attention to detail are necessary.
• Team player with good problem-solving, verbal and written communication skills.
• Ability to manage people, encourage teamwork and drive decisions.
• Knowledge of FDA regulations, GLP and GMP is beneficial.

Responsibilities

• Identify and assess regulatory and quality risks in activities and processes per regulatory rules and Baxter quality practices.
• Lead ongoing, daily departmental operations.
• Supervise and develop direct reports where applicable; hire, evaluate and train staff.
• Perform in-depth internal assessments using objective evidence of risks and magnitude.
• Gather information via interviews, flow charts and other techniques to assess risk and process adequacy.
• Develop plans to correct identified risks and implement approved corrective actions.
• Write, review and revise SOPs to meet requirements; coordinate changes with stakeholders.
• Support audits and external assessments; assist with regulatory submissions as needed.
• Serve as SME and provide training on relevant areas; maintain a clean, safe work area following 6S.

Skills

Interpersonal skills

Problem solving

Verbal/written communication

Team leadership

Education

Bachelor's degree in engineering or science

Job description

This is whereyour 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.

Your Role at Baxter

Position Summary

Responsible for providing Quality support and oversight via process/area projectand process development.

Your Team

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.

What we offer from Day One

• 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

What you'll be doing

• Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter quality practices.
• Leads ongoing, daily departmental operations.
• May include the supervision of assigned personnel in achieving defined quality goals in an efficient, accurate and timely manner; Interview/hire, evaluate, train and develop direct reports
• Perform in-depth internal assessments and evaluations by collecting and analyzing accurate, objective evidence regarding risks and their magnitude.
• Assessments and information gathering may be through in-depth employee interviews, flow charting and other informational gathering techniques.
• Determine the logic, adequacy and effectiveness of processes, systems and related requirements.
• Develop plans to correct identified risks including areas of non-conformance, inform management and implement approved corrective action plans.
• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Plant, Regulatory Requirements, etc.
• Support external assessments or audits. Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.)
• Serve as Subject Matter Expert (SME) and provide training to local employees as needed on relevant area(s) Other duties, tasks or projects as assigned. Sustain a clean and safe work area using 6S principles
• Learn, understand and apply rigorous quality standards, Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMP)

What you'll bring

• Bachelor's degree strongly preferred. Degree inengineering orscience preferred.
• Must be at least 18 years of age and possess a High School Diploma or GED.

• Strong interpersonal skills and great attention to detail are necessary.
• Must be a strong team player with good problem solving, and good verbal and written communication skills.
• Must have the ability to manage people, encourage teamwork and drive decisions.
• Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices as appropriate.
• 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.

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.

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 $68,000-$93,500 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 upon location, skills and expertise, experience, and other relevant factors. This position may also be eligible for discretionary bonuses.

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.

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.

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.

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

65 Pitts Station Rd|Marion, NC 28752|United States of America