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.
The incumbent will be responsible for ensuring compliance with the Quality System Regulation regarding Quality and Manufacturing Processes and Methods. To perform effectively the incumbent must be knowledgeable of all processes, product, specifications and quality functions. Responsible for the review and audit of the process in a day to day basis for compliance to cGMP and Management timeliness metrics.
Essential Duties and Responsibilities:
1. Revise and approve all documentation related to the areas of responsibilities is complete, accurate, and in compliance with the procedures, specifications, per shift. Documentation such as: In Process Checker Charts, Product Retention Records, Control Charts, Mold Approvals, Batch Records related and others.
2. Manufacturing audits per shift of machine parameter and/or set-ups for compliance as well as the product manufactured.
3. Perform shift audits of sampling techniques testing skills and all documentation performed by the TIQ's.
4. Immediate notification and awareness to Quality Management of potential Quality situations.
5. Assist protocol execution and coordinate for execution of special instructions (e.g. Product Retentions) for Quality Assurance.
6. Provide training as required on: Good Documentation Practices, Good Manufacturing Practices, Total Integrated Quality, Area procedures and others.
7. Provide support regarding mold approval test execution and mold start up evaluations (if applied).
8. Gather, analyze, audit and interpret data using procedures to predict trends and recommend process improvements that would impact favorably on product quality, scrap reduction, DPM reduction, complaints reduction, price of non-conformance reduction and others. Maintains, revise and audits control chart and compute control chart limits as required.
9. Assure by shift audits and verifications that all machinery, equipment, tools or any other measurement, monitoring material complies with Corporate, GMP and other regulatory requirements. Follow applicable Behavior Based Quality assessments.
10. On a monthly basis support with data gathering for Quality Indicators including DPM’s, Pareto Analysis on responsibility areas.
11. Submit improvements and/or modifications to specifications and Standard Operating Procedures.
12. Maintain good timely communication and awareness of process failure and trends with the internal and external customers/suppliers. (if apply)
13. Coordinate and perform the certification of the Total Integrated Quality (TIQ) personnel.
14. Perform special projects related to responsibility areas.
15. Document the verification / revision (ex: checker chart) and/or electronically (ex: POMs) of the required information to comply applicable procedures and specifications. This information includes but is not limited to process parameters, lots, amount of production, quality checks and others.
16. Responsible for conducting EHS inspections to identify and correct safety hazards and environmental aspects. Follow the EHS applicable procedures and analyze EHS incidents (including near misses) to find causes and take corrective action.
17. Observe data privacy policies at all time.
18. Provide support on Software application audits execution.
19. Assist on the generation and investigation of non-conformities
QUALIFICATIONS:
Knowledge in Data Entry – Microsoft Office Software. Basic computer knowledge is required Experience in measurements instrumentation. Good interpersonal skills. Willing to travel occasionally.
PHYSICAL DEMANDS:
Light Work: Exerting up to 20 pounds of force occasionally and/or a 10 pounds of force frequently, and/or a negligible amount of force constantly to move objects. Physical demands requirements are in excess of those for Sedentary Work. Even though the weight lifted may be only a negligible amount, a job should be rated Light Work: (1) when it requires walking or standing to a significant degree; or (2) when it requires sitting most of the time but entails pushing and/or pulling of arm or leg controls; and/or (3) when the job requires working at a production rate pace entailing the constant pushing and/or pulling of materials even though the weight of those materials is negligible.
EDUCATION AND EXPERIENCE:
Bachelor Degree Science. At least two years of experience dealing with related job on Medical Device Industry.
LANGUAGE:
Bilingual (English & Spanish).
DISCLAIMER STATEMENT:
Las declaraciones mencionadas anteriormente describen la naturaleza general y el nivel de trabajo que se les requiere a los empleados a quienes se les asigna esta clasificación. No pretende constituir una lista exhaustiva de las responsabilidades, tareas y destrezas requeridas para el personal así clasificado.
The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified.
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.
EEO is the Law
EEO is the law - Poster Supplement
Pay Transparency Policy
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.