Quality Technician Jobs

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

Incumbent will be responsible for insuring compliance with the Quality System Regulation regarding quality and manufacturing processes and methods. In order to perform effectively the incumbent must be knowledgeable of all processes, product, specifications and quality functions. Manages exception situations and make decisions during production process. Monitor quality improvement for the manufacturing operation.

ESSENTIAL DUTIES AND RESPONSIBILITIES

Responsible for routine manufacturing audits of machine parameter and/or set-ups for compliance as well as the product manufactured.

Perform routine audits of sampling techniques testing skills and all documentation performed by the Quality Lead.

Performs and manages assessments of process, systems, and products to ensure cGMP's compliance.

On a daily basis solves quality and equipment issues.

Responsible to determines and measures quality and reliability of products.

Understands product flow in order to determine product traceability and downstream effect on decisions.

Coordinates Stability Program to assure compliance with applicable specifications.

Coordinates the Printed Material Sampling Controls for samples send outside Jayuya Plant.

Batch Record Review for product Manufacture, if required.

Performs audits (daily, weekly, monthly, annually), reports and fill out all documentation to comply with all standards (to machinery; to the process; monthly safety audit; procedures; verify machinery parameters). Assures that Baxter do not incurs in any quality violation.

Trains manufacturing personnel in TIQ process, Line Clearance process and Visual Inspection.

Coordinates, performs process and equipment validations protocols.

Fill out, reviews and maintains all reports as required (daily, weekly, monthly, annually) in compliance with cGMP's, cGDP's and other internal and external standards (eg. Product Retention Records, Printed material, Manufacturing Checker Charts, Stability, Sterility, FOR & FOC ).

Maintains update knowledge of all relevant SOP's and specifications.

Submit changes to SOP's and standards to keep quality of the area.

Ability to solve daily quality and equipment issues to assure the most efficient, effective and safety product release.

Coordinates monitors and performs sampling handling process, and send them outside (other Baxter facilities) as required.

Trains manufacturing and quality personnel, review the quality department training manuals.

Teamwork oriented, have an active participation in Plant teams.

Should be able to work on special projects as assigned.

Manage audits and approves standard operating procedures as "SAR".

Willing to work extra hours, any shift and during weekends when required.

Certify new employees in the operations areas.

Assists the supervisor when it's required.

Supports the manufacturing area when it's necessary.

Must be able to communicate effectively at all Plant Levels.

Must be able to keep the work area in the most clean and order conditions.

Responsible for File Sample Area that includes, but not limited to the following:

File samples areas daily audit, temperature review, replacement and documentation

Perform the annual inspections to the samples, storage and document all the activities related (GDP compliance).

Maintain the area organized and clean.

Coordinate the movement of the expired samples and the discard of the applicable samples.

Perform the APR report assigned in a monthly basis.

Perform a monthly report with the samples inspected and send it to the Quality Operational Management.

QUALIFICATIONS

EDUCATION and/or EXPERIENCE

Bachelor's degree; two year of previous experience (preferable).

LANGUAGE SKILLS

Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization. Fully bilingual (English and Spanish languages).

MATHEMATICAL SKILLS

Ability to add, subtract, multiply, and divide in all units of measure, using whole numbers, common fractions, and decimals. Ability to compute rate, percent and interpret bar graphs.

REASONING ABILITY

Ability to apply common sense understanding to carry out detailed but uninvolved written or oral instructions. Ability to deal with problems involving a few concrete variables in standardized situations.

CERTIFICATES, LICENSES, REGISTRATIONS

cGMP's Training, Quality Control Exam (at HR Department), Quality Tech. Certification, Forklift license, and other trainings, certificates or licenses that the immediate supervisor refers.

COMPANY REGULATORY COMPLIANCE

Observes and promotes company security, industrial hygiene, cGMP's, procedures and other security measures already established by the company; should inform any violation.

PHYSICAL DEMANDS

While performing the duties of this job, the employee is regularly required to sit. The employee is occasionally required to stand; walk; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. The employee must occasionally lift and/or move up to 20 pounds. Specific vision abilities required by this job include close vision, color vision.

WORK ENVIRONMENT

While performing the duties of this job, the employee is frequently exposed to extreme cold. The employee is occasionally exposed to moving mechanical parts; high, loudly places. The noise level in the work environment is usually moderate.

SAFETY EQUIPMENT and/or EQUIPMENT

The employee is required to use the appropriate Safety Equipment that Baxter requires to comply with all Safety and Security rules (in Regulated Areas), such as: safety glasses, safety shoes, uniform, special safety suit, gloves, etc.

While performing the duties of this job, the employee is required to use the appropriate equipment: forklift; hand lift; calculator; quality laboratory specialized equipment, solutions and tools; computer; calibrated rules; office supply; telephone, copy machine, fax machine.

DISCLAIMER STATEMENT

The above statement are intended to describe the general nature an level or 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.

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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