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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.
JOB PURPOSE:Direct and organize the operations Chemical Laboratory. This includes the participation in the development of Jayuya policy systems and standard operating procedures for specifications, and directions for testing in the following areas: Raw Materials, In- Process Materials, Finished Products, Stability Program, Method Transfer. Responsible for the compliance to all government regulations, company policies and procedures related to the assigned areas. Responsible for the validation activities related to the laboratory, including change control and Quality Monitoring. The primary result of this position is to assure all activities carried out in the laboratories are properly executed in accordance with FDA regulations and USP standard and that the services are carried out in an expeditious and cost-effective manner maintaining a high degree of compliance meeting the overall business priorities and schedules.ESSENTIAL DUTIES AND RESPONSIBILITIES:- Coordinates all Chemical Laboratory activities with Manufacturing and Supply Chain group.
- Manage the activities of the Laboratory Operations. Responsible for the supervision and training of exempt and non-exempt personnel in the group.
- Responsible for the validation program at the chemical laboratory including but not limited to equipment, process, test methods, and software among others.
- Establishes and implement laboratory standard operating procedures and policies according to global policies and regulations.
- Manage the method transfer program for the laboratory, where applicable. Active participation in process validation and revalidation programs. Responsible for the analysis of validation samples.
- Identify and implement with the help of R & D (if needed) the improvements in laboratory testing methods and automation to upgrade the laboratory efficiency, consistent with lowest possible cost objectives of business.
- Participate in the approval, revision and implementation of raw materials, in process, finished product, and other documents.
- Ensures all changes needed are managed through the applicable change control system.
- Accountable for the Product Stability Program.
- Assure the staff, supervisors, and employees follow all federal, state, and company requirements, such as OSHA, EPA, FDA.
- Performs weekly, monthly and annual reports as required by Plant Senior Managements, policies and procedures.
- Conducts and approved laboratory investigations.
- Conducts trend analysis including data of Annual Product Reviews.
- Ensures that all analyst assigned to perform testing have been adequately trained in the test and the methodology according to Good Laboratory Practices delineated in cGMP's, company standards and regulatory requirements for achieved accurate laboratory testing results (FDA Guideline for laboratory operation).
- Audit in a routine basis the analyst's performance and accuracy of all and documentation performed in the laboratory to ensure the effectiveness of the training performed.
- Develop and owns the departmental budget and capital budget. Ensure to keep technologies, software, equipment updated and submit capital requests as needed.
- Ensure all services contracts applicable to the laboratory are maintained and updated.
QUALIFICATIONS
- EDUCATION and/or EXPERIENCE
- LEADERSHIP SKILSS
- LANGUAGE SKILLS
- MATHEMATICAL SKILLS
- REASONING ABILITY
- CERTIFICATES, LICENSES, REGISTRATIONS, EXAMS
- COMPANY REGULATORY COMPLIANCE
- PHYSICAL DEMANDS
- WORK ENVIRONMENT
- SAFETY EQUIPMENT and/or EQUIPMENT
The successful candidate for this job may be required to verify that he or she has been vaccinated against COVID-19, subject to reasonable accommodations for individuals with medical conditions or religious beliefs that prevent vaccination, and in accordance with applicable law.
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.
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