CAPA Quality Associate - 1st Shift

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.

Responsibilities

• Support the execution and maintenance of Quality Compliance processes and procedures in accordance with site requirements, Standard Operating Procedures (SOPs), and current Good Manufacturing Practices (cGMP).
• Support the Corrective and Preventive Action (CAPA) process, including record initiation, documentation, tracking, follow-up, and timely progression of assigned actions.
• Support Nonconformance Report (NCR) activities and other quality records, as assigned.
• Monitor open quality records and assist with follow-up of actions approaching or exceeding established due dates.
• Support the collection, tracking, trending, and presentation of quality metrics, including CAPA/NCR timeliness, Right First Time (RFT), overdue records, and other applicable compliance metrics.
• Assist with the preparation of routine Quality Compliance reports, dashboards, and presentations.
• Review quality records for completeness, accuracy, and adherence to applicable procedures.
• Assist with investigations, root cause analysis, corrective actions, and effectiveness activities, as assigned.
• Identify documentation or compliance gaps and escalate issues to Quality leadership as appropriate.
• Support continuous improvement activities related to CAPA, NCR, documentation, and other Quality Compliance processes.
• Assist with audit and inspection readiness activities, including organization and retrieval of supporting documentation and evidence.
• Communicate quality and compliance activities, record status, and identified issues clearly and in a timely manner.
• Collaborate with Manufacturing, Quality, Engineering, and other applicable functions to support completion of quality system activities.
• Participate in Quality and Manufacturing improvement projects using appropriate problem-solving, Lean, and process improvement tools.
• Maintain working knowledge of applicable plant systems, procedures, documentation, and Quality Compliance processes.
• Manage and prioritize multiple assigned tasks and quality records to support established timelines.
• Comply with applicable Environmental, Health, and Safety (EHS) requirements.
• Maintain a clean, organized, and safe work environment in accordance with 6S principles.
• Notify the appropriate supervisor or manager when safety, quality, mechanical, or compliance issues are identified.

Knowledge, Skills, and Abilities

• Basic understanding of quality systems and cGMP requirements.
• Ability to learn and apply CAPA, NCR, and other Quality System procedures.
• Strong attention to detail and documentation accuracy.
• Ability to review information, identify discrepancies, and escalate concerns appropriately.
• Strong organizational and time-management skills.
• Ability to manage multiple assignments and priorities.
• Effective written and verbal communication skills.
• Ability to work effectively both independently and as part of a cross-functional team.
• Basic analytical and problem-solving skills.
• Proficiency in standard computer applications used for documentation, data analysis, and reporting.
• Ability to perform assigned responsibilities with appropriate supervision.
• Ability to travel as needed to perform job responsibilities.
• Ability to sit, stand, and/or walk for extended periods.
• Ability to reach above shoulder level and bend or stoop as required.
• Must meet applicable visual acuity requirements as defined in Baxter Cleveland Human Resources Procedure 1.04.

Required Education and Experience

• Bachelor’s degree in Life Sciences, Science, Engineering, Quality, or a related discipline, preferred.
• Basic understanding of quality systems and regulated manufacturing practices preferred.
• Experience in an FDA-regulated or cGMP manufacturing environment, preferred.
• Experience with CAPA, NCR, investigations, quality records, or compliance activities preferred.
• Lean Manufacturing and/or continuous improvement experience preferred.
• Six Sigma training or certification is a plus.

Other Duties as Assigned This job description is not intended to provide a comprehensive listing of all activities, duties, or responsibilities required of the employee. Duties, responsibilities, and activities may change based on business and operational needs. Overtime may be required.

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 $68,000 - $85,000 annually. We may pay more or less than 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. 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 cannot sponsor or transfer sponsorship of an employment visa.

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.

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