Catano, Puerto Rico
20 hours ago
Quality associate II

This is where you save and sustain lives

At Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. You’ll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients. 

Baxter’s products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.

Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work. 

Join us at the intersection of saving and sustaining lives— where your purpose accelerates our mission. 

Your role at Baxter
Responsible for providing Quality support and oversight via direct staff supervision or process/area responsibilities in the Puerto Rico Global Logistics Center (GLC). Identify and assess regulatory and quality risks in activities and processes according to regulatory agency rules and guidelines and Baxter
quality practices. Demonstrate effectiveness in task completion, decision-making, empowerment of others, exception management, training, team leadership, and problem solving.

What we offer from day 1

Medical, Dental, Disability and Life Insurance coverage

Vision Plan

Paid Vacation Days and Paid Holidays

Paid Parental Leave

Retirement Plan 165e

Employee Stock Purchase Program

Educational Assistance Plan


What you'll be doing

• Leads ongoing, daily departmental operations within the Puerto Rico GLC Quality organization

• Leads Baxter products that fall within the scope of the U.S Drug Supply Chain Security Act (DSCSA) and related process.

• Participant in site initiatives and training related to Lean continuous improvement and iCare.

• Identify, investigate, and write records related to exceptions and nonconformances. Identify and execute corrective action plans as required.

• Write, review, analyze and revise written Standard Operating Procedures (SOPs) and submit procedural changes as needed to meet Corporate, Divisional, Site, Regulatory Requirements, etc.

• Perform customer complaint distribution investigations

• Perform 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.

• Support external audits and help ensure site compliance / audit ready status Be directly involved in multiple process/facility improvement projects

• 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)

Manage activities of self and others in achieving defined quality goals in an efficient, accurate, and timely manner

Other duties, tasks or projects as assigned.

What you'll bring:

Bachelor's degree required (preferably in science, engineering or equivalent field). Minimum of 3-5 years of experience in Quality, or related field in the medical products/pharmaceutical industry.

• 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.

• 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

Baxter is committed to supporting the needs for flexibility in the workplace. We do so through our flexible workplace policy which includes a required minimum number of days a week onsite. This policy provides the benefits of connecting and collaborating in-person in support of our Mission. The flexible workplace policy is subject to local laws and legal requirements. At its discretion, Baxter may decide to adjust, suspend, or discontinue as business needs change

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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