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QA Inspector

Req #: JR - 050816 Location Hayward, California, United States Job Category: Quality Control Date Posted: 01/06/2022

Overview

This is where you make a difference in our patients’ safety. As a member of the Baxter Quality team, you will play an essential part in our mission of saving and sustaining lives. Quality is important throughout the entire product lifecycle and works collaboratively with all areas of the organization. Because Quality touches everything Baxter does, a role in Quality provides many opportunities for growth, learning and a successful career that has a daily impact on people’s lives.

  • Support for Parents

  • Continuing Education/
    Professional Development

  • Employee Health &
    Well-Being Benefits

  • Paid Time Off

  • 2 Days a Year to Volunteer

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Success Profile

What makes a successful Quality team member at Baxter? Take a look at some of the top traits we’re looking for and see if you’re a fit.

  • Detail Oriented
  • Continuous Learner
  • Courageous
  • Collaborative
  • Critical Thinker
  • Influential

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QA Inspector

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. 

Summary

This position is responsible for endorsing process and product quality through the routine assessment of in-process materials and finished goods. In addition, to provide continuous improvement to the department through Quality Systems. Responsible for the inspection and verification activities in the manufacturing process. Must adhere to current Good Manufacturing Practices at all times.

Essential Duties and Responsibilities

  • Inspection and release of production and in-process materials and components.
    Verify various manufacturing steps and techniques.
  • Inspection of raw materials finished goods and in-process components.
    Tagging and de-tagging of discrepant material.
  • Release of packaged product into warehouse.
    Maintenance and disposal of quality retains.
    Archival of quality records.
  • Any additional task assigned by the Supervisor.
  • Support and participate with management during internal and external inspections as   needed.
    Initiate minor documentation revisions.
  • Support the corrective and preventive action process by recommending course of action and coordinating activity during exception situations.
  • Responsible for gathering, analyzing, summarizing, and distributing process-relevant data.
  • May train new staff members.
  • Participate in continuous improvement initiatives such as Lean and 6-Sigma.
  • Review documentation for accuracy and compliance to procedures, obtain resolution on areas identified as non-conformance. Interpret and evaluate results in terms of acceptability to standards, procedures, and regulatory requirements.
  • Prepare and issue reports. Manage database including all QA personnel with the use of the Access program (trouble shooting, etc.) and modifications to the databases such as creating new reports, queries, forms, tables, etc.
  • Participate in internal or external assessments, as required. Support process with timely closure of observations/audit items.
  • Assist with audits of various reports (Protocols, Qualifications, Regulatory Submissions, etc.). Identify areas of non-conformance and inform management.
  • Provide training to the quality department employees as areas are identified (e.g., Original Documentation Practices, Standard Operating Procedures, Quality Leadership, QA Database, etc.).

Qualifications

  • Good working knowledge of Windows based applications.
    Ability to demonstrate strong organizational skills.
  • Exercise judgment within defined procedures and practices.
  • Work effectively independently and in team environment is a must.
    General knowledge of applicable quality and regulatory standards and regulations.
  • General working knowledge in Lean and other continuous improvement tools.
    Must be a strong team player with good problem solving, and good verbal and written communication skills.
  • Must be able to handle multiple projects concurrently, have computer experience and have knowledge of FDA Regulations, Application of Good Laboratory Practices, and Application of Good Manufacturing Practices.
  • Knowledge of GMP documentation and FDA required.
  • Demonstrated attention to details and accuracy, required.
  • Must have good communication skills.
  • General knowledge of quarantine and warehouse operation helpful.
  • May be required to work flexible hours and overtime on short notice

Education and/or Experience

  • Bachelors with 0-2 years related experience or Associates with 1-3 years-related experience or High School diploma with 2-4 years of experience.
    Experience in a pharmaceutical or Biotech industry helpful.
  • Must be familiar with cGMP and FDA requirements.
    Knowledge of aseptic techniques may be required.

Physical Demands

  • Regular attendance is necessary to perform the essential functions of the job.
  • Light work, frequent lifting up to 40lbs; frequent standing/walking. Frequent standing and walking.
  • Vision Requirement: Near point corrected vision must be at least 20/25. Vision checkup will be performed on an annual basis.
  • Inspectors shall pass a standard eye test including a near vision acuity test. The results of the eye test must be at least 20/25 for near point corrected vision within both eyes (tested together) or country specific equivalent, e.g., 80% or 0.8 (European), or a Jaeger card score of
  • If employees fail to meet the minimum vision standard, they should be referred to their optometrist for further correction. If the vision cannot be corrected, the employee must be assigned to other areas.

Working Environment

  • No travel required.
  • Normal office working conditions: computer, phone, files, fax, copier
  • Personal Protective Equipment: Latex-Free Gloves, safety shoes and safety goggles are required during the inspection process.

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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 
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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.

050816

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Christelle

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Lorena

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

Gary

Hear from Our Employees

Our company is enriched by a diverse population of individuals in more than 100 countries that work to solve, innovate, manufacture and drive better healthcare options for patients around the world.

Christelle

Meet Christelle, Senior Quality Manager in Malta

"I was an Engineering Graduate with a Master's in Business Administration, and was more inclined toward working with people than with machines. When I came across an opportunity to work with Baxter as a Quality Engineer, it was the perfect combination: a manufacturing environment and a role that required me to collaborate with multiple teams daily. Baxter's mission of saving and sustaining lives gives me all the purpose and fulfilment I need."

Lorena

Meet Lorena, Senior QA Associate in London, UK

"I am registered pharmacist in the UK with experience with drug products and final product release. I am very dedicated to my work and accurate in details to ensure correct assessment is provided to our customers to ensure patients' safety."

Gary

Meet Gary, Quality Research Manager in Singapore

"I have always enjoyed working at Baxter and I find here to be a great place to work! Management truly cares for you, and invests time and resources to support your career goals and aspirations. My current role provides me the opportunity to work with culturally diverse teams, bringing different talents together, learning from one another and working toward a common goal and mission."

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