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  • 2 weeks ago

jobs description

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.

Shift 1

JOB PURPOSE

Responsible for the compliance within Critical Systems and Calibrations, Sterilization, Risk Management, Process Validations, Equipment Qualifications, MVP and assigned areas to all government regulations, company policies and... procedures. Provides technical support and guidance to ensure process controls and quality compliance in areas of responsibility. Assuring all activities carried out through the site are properly executed complying with the regulations, company policies and procedures. Focus on continued improvement, quality compliance, and customer satisfaction.

A key objective of this role is to ensure cGMP is consistently followed for the mentioned processes and to be always inspection ready by ensuring quality and compliance are consistently built into day-to-day operations. The role entails a range of functions, from management of exempt and hourly personnel to management of product quality issues to continuous improvement.

The person in this role manages multiple subordinates in different areas, is expected to exercise leadership skills to drive for right first-time execution in daily operations, influencing others to display the right behaviors, being able to influence across boundaries and levels, confronting and challenging with courage while working in collaboration with others. The role requires taking decisions based on data, information, inputs from Subject Matter Experts, cGMP expectations, Baxter’s Quality System, while applying Risk Management principles. The person in this role must ensure escalation of significant quality issues to the Quality Management Representative (QMR) and Plant Manager within a timely manner.

ESSENTIAL DUTIES AND RESPONSIBILITIES
• Responsible of assigned programs (e.g., Sterilization Process, Parametric Release, Risk Management, MVP, Validations Process, etc.) from the quality standpoint to ensure compliance. Lead, individually and through subordinates, the revision of documentation and approval process.
• Lead site qualifications and continuous process validations from a quality perspective to ensure requirements are met.
• Provide guidance and technical expertise of regulatory in Risk Management strategies and processes.
• Assess risk associated with non-conformances complaints, audits, change control etc. and ensure the site process FMEA is evaluated and updated as needed to include new risks.
• Manages the activities to maintain the site Master Validation Plan.
• Manage the Technical Services team to assure site validations activities are performed in compliance with regulations and corporate requirements.
• Provide guidance and support to steam sterilization process, Critical systems, Calibrations and validations to assure quality compliance.
• Participate in audits as Subject Matter Expert of the designated areas. In addition, assure that team participates in audits.
• Identifies and leads continuous improvements projects that provide fast, sustainable, and low-risk/high-reward benefits for the assigned areas.
• Supports areas initiatives to ensure compliance with internal and external regulatory requirements.
• Implement lean culture tools throughout the assigned areas.
• Assure department procedures are updated and in alignment with regulatory requirements and company policies.
• Review and approve nonconformance investigations as quality representative.
• Provide quality requirements for change control, validations, and investigation activities.
• Manage Technical Services key performance metrics.
• Develops budget for the department and ensures adherence to the budget.
• Oversee the adherence of project milestones to be able to comply with the established projects goals.
• Manages, coach, engage, train, and develop direct and indirect reports. Responsible for hiring direct reports.

GMP Oriented
• Must keep the work area in the cleanest and orderly conditions.
• Performs visits to areas of responsibility, document findings and suggestions to improve processes.
• Revises, implements changes and audits existing specifications and SOP's; creates new ones as required.
• Develops and implements procedures on established policies.
• 21 CFR Regulations compliance oriented.
• Safety Regulations OSHA compliance oriented.

QUALIFICATIONS

EDUCATION and/or EXPERIENCE

Bachelor’s degree (BS) in industrial, mechanical, chemical, or electrical engineering; with at least 8 years of experience in medical devices or pharmaceutical operations desirable. Experience in equipment, process, systems and or computerized systems validation. CQE (desirable). ISO 9001 current version and 21 CFR Regulation Part 210 and 211 or Part 820 (desirable). Excellent communication skills. Lean/Six Sigma tools knowledge (preferred).

LANGUAGE SKILLS

Ability to read, analyze, and interpret professional journals, technical procedures, and governmental regulations. Ability to write reports and procedure manuals. Ability to effectively present information and respond to questions from groups of managers, internal or external audits, customers, immediate supervisor, and the general public. Fully bilingual (written and oral), English and Spanish languages.

MATHEMATICAL SKILLS

Ability to apply advanced mathematical concepts such as exponents, logarithms, quadratic equations, and permutations. Ability to apply mathematical operations to such tasks as frequency distribution, determination of test reliability and validity, analysis of variance, correlation techniques, sampling theory, and factor analysis. Knowledge in statistical software and calculations.

REASONING ABILITY

Ability to define problems, collect data, establish facts, and draw valid conclusions. Ability to interpret an extensive variety of technical instructions in mathematical or diagram form and deal with several abstract and concrete variables.

Ability to deal with problems involving several concrete variables in standardized situations. Technical writing and reporting skills.

CERTIFICATES, LICENSES, REGISTRATIONS, TRAININGS

cGMP's training and other trainings, certificates or license that immediate supervisor refers. Green Belt certified desirable.

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 must occasionally lift and/or move up to 20 pounds. Noise level in the work environment is usually moderate. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT

While performing the duties of this job, the employee is occasionally exposed to wet and/or humid conditions; high, precarious places; fumes or airborne particles; toxic or caustic chemicals; outside weather conditions; extreme heat; and vibration. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

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, and any other equipment necessary in order to protect the health and safety of the employee. The incumbent must be able to use industrial and non-industrial computerized system; manufacturing and laboratory equipment; telephone; office supply; copy machine; fax machine; computer as required.

DISCLAIMER STATEMENT

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.

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.

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
Puerto Rico

salary-criteria

Apply - Quality System Manager Puerto Rico