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.
Summary:
This person will oversee the compliance with all the regulatory requirements related to Critical Systems. Critical Systems will include the following equipment or systems: Water for Injection, Manufacturing Air Conditioning, Compress Air and Vacuum and process controls (Pest Control). This position supports Engineering area in Nonconformance Investigation and audit observation related to Critical System, by using technical writing skills in accordance with applicable regulations, guidelines, and Baxter quality system requirements for the implementation of CAPA records, action testing/verifications and/or implementations, mitigation actions, effectiveness check criteria
Essential Duties and Responsibilities:
1.Reviews changes in specifications (Certification Document Reviews-CDRs) and compliance with local SOP's.
2.Perform Gap assessments between GQP's, Specs and SOP's.
3.Identify gaps between PMs, Pest Control, WFI and Compress Air
4. Perform or evaluated the annual review report require for the critical systems.
5.Assures compliance of procedure related to utilities maintenance.
6.Support in the evaluation of the observation related to Critical System under the internal and external audit process.
7.OCP evaluations for validations and Non-conformance investigations.
8.Responsible for execution and documentation of the non-conformance investigations in order to identify the root cause(s) and contributing factors, as applicable. Complete all investigation phases within the required timeframe and in accordance with the requirements set-forth in applicable procedures.
9.Develop investigation strategy by coordination of activities such as brainstorming sessions with multidisciplinary team, process observation, product (samples) evaluation, interviews, and follow-up meetings as mechanism to review the progress of the investigation phase.
10.Assists in identifying with the multidisciplinary team the appropriate mitigation actions, Corrective and Preventive actions, as applicable, and in determining the Effectiveness Check Criteria.
11.Execute queries and reports from electronic system, as necessary.
12.Perform SOP changed to improve, process or by CAPA actions.
13. Ensure timely follow-up of corrective and/or preventive action, monitoring CAPA process from to beginning to the end.
14.Promote a zero-harm workplace, and assure that required EHS resources are available and that all applicable EHS practices and rules are being followed by supervised employees.
15. Look for simplification in SOP's and process forms such as housekeeping, Boiler Room operation.
16. Information organization and data analysis for compliance assessment, audits and investigations.
Physical Demand:
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.
Qualifications:
Fluent in written and spoken English Knowledge of Quality Systems, Trackwise electronic system preferable Application of Good Manufacturing Practices Leadership capabilities/skills Strong analytical and problem solving skills Good interpersonal/communication/influencing/negotiation skills. Must be willing to travel occasionally. Desirable Technical Writing skills certification or equivalent. Knowledgeable in ISO9000 and ISO 13485 International Standards and FDA 21 CFR 820 and FDA 21 CFR 211 regulations.
Education and/or Experience:
Bachelor's Degree required in Engineering filed with 0-2 years of experience.
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.