Inspector, QA

Company: Baxter Healthcare
Location: Hayward
Posted on: April 4, 2021

Job Description:

Req #: JR - 037228 Location Hayward, California, United States Job Category: Quality Control Date Posted: 03/24/2021 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 Paid Time Off 2 Days a Year to Volunteer 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. 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 raw materials and in- process materials. In addition, to provide continuous improvement to the department through Quality Systems. Must adhere to current Good Manufacturing Practices at all time. --- Perform the timely release of raw and in-process materials, making sure documentation is available and correct for release. Must adhere to current Good Manufacturing Practices at all times. --- Ensure that all inspection and chemical sampling are properly completed and documented. --- Review quality assessment and testing and determine whether to accept or reject materials or product during the inspection process. --- Initiate minor document revisions. --- Tagging and de-tagging of discrepant material. --- Release of packaged product into warehouse. --- Maintenance and disposal of quality retains. --- Control and verification of patient labels. --- Replace and monitor daily magnehelic gauge and freezer charts assigned in building D warehouse. --- Archival of quality records. --- Any additional task assigned by the supervisor. --- Support and participate with management during internal and external inspection 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. --- 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. --- Participate in internal or external assessments, as required. Support process with timely closure of observations/audit items. --- Assist with audits of various report (Protocols, Qualifications, Regulatory submissions, etc.). Identify areas of non-conformance and inform management. Qualifications --- May be required to work flexible hours and overtime on short notice. Education/Qualifications --- 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 pharmaceutical or Biotech industry helpful.
--- Knowledge of aseptic techniques may be required. --- General working knowledge in Lean and other continuous improvement tools. --- Must be 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. Physical Demands/Working Environment --- Standing. Particularly for sustained periods of time. --- The worker is required to have visual acuity to determine the accuracy, neatness, and thoroughness of the work assigned. --- The worker is subject to hazards. Includes a variety of physical conditions, such as exposure to low temperatures or exposure to chemicals. #IND-USOPS 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.

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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. 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." 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." 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." Join Our Talent Community This website is owned and operated by Baxter Healthcare Corporation [One Baxter Parkway, Deerfield, IL 60015-4625] ("Baxter") acting as data controller for itself and on behalf of all of its affiliates and subsidiaries. By clicking on the "Subscribe" button I declare that I have read the Privacy Policy and consent to Baxter processing my personal data for the purposes of joining the Baxter Talent Community: to provide me via email with job offers in the area of my interests and to provide me information about Baxter. I am aware that I have the right to withdraw my consent by clicking the "Unsubscribe" option in the emails I receive from Baxter. First Name Last Name Phone Number Email Address Select Interests Select a job category from the list of options. Search for a location and select one from the list of suggestions. Finally, click "Add" to create your job alert. Job Category Location*

• Quality Control, Hayward, California, United States Remove Learn about the four key components of our global inclusion strategy. Baxter touches the lives of millions of people around the world every day. Our company is enriched by a diverse population of individuals in more than 100 countries. Patients' journeys inspire our work and drive our commitment to advance new standards of care. Heroic work by healthcare providers and first responders to care for those with COVID-19 inspires us all.

Keywords: Baxter Healthcare, Hayward , Inspector, QA, Other , Hayward, California