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Sr. Analyst, Quality Lab

Req #: JR - 074241 Location Marsa, Il-Marsa, Malta Job Category: Quality Control Date Posted: 07/06/2022

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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Sr. Analyst, Quality Lab

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

The QA Laboratory analyst is responsible to perform and assist in all GLP practices within the QA micro laboratory such as laboratory stock control, cleaning, waste disposal and good hygiene practices. In addition, the person chosen will be reviewing routine ETO sterilisation cycles prior to batch release, peform routine microbiological and environmental testing as well as analytical, environmental and microbiological validations and compilation of protocols/reports. The QA laboratory analyst shall work under the supervision of the QA Section Manager in order toperform critical systems monitoring duties for Baxter Ltd. The position is also trained to assist as back-up inselected functions as requested by theQA Section Manager and in all functions related to the Q.A. laboratory analyst duties whilst also being responsible for Gamma dose settings and quarterly dose audit sample coordination and sterility testing and update documentation such as SOP‘s as requested by the QA Section Manager.

Essential Duties and Responsibilities.

  • This position is also responsible to consider the aspects for Environmental health and Safety procedures to ensure that all activities within this role do not jeopardise the safety of the employees and the environment.
  • Performing, reviewing, trending and supervision of routine and environmental testing, includingmanagement of the environmental testing schedule.
  • LAL Endotoxin tests on finished product, waters and incoming components.
  • Routine checks on untreated and treated water.
  • Surface contamination testing of cleanrooms.
  • Finished product and in-process component bioburden.
  • Annual re-qualification of production and controlled areas.
  • Maintaining QC microbiological type cultures.
  • Maintaining the laboratory in good order and in a hygienic state and 6s status.
  • Management of the Stock control system and ordering of new lab equipment or other stock items
  • Working on research projects.
  • Sterilisation and decontamination of microbiology equipment.
  • Media and reagent preparation.
  • Issue and review of SOPs dealing with laboratory procedures related to environmental testing.
  • The QA laboratory analyst is also responsible to perform his routine work in such a way as not to pose ahazard to himself, fellow workers in the plant and the laboratory the plant facilities and to the environment ingeneral.
  • The incumbent is responsible of following Baxter Environmental, Health and Safety procedures/ policiesand Best Demonstrated Practices. The QA laboratory analyst is also responsible of notifying the QA SectionManager in case of observing any Health and Safety Hazard.
  • Review of routine sterilisation cycles, and the related batch file documentation.
  • Quarterly Gamma sterilisation validations.
  • Gamma Sterilization (including dose setting , dose mapping , dose audits and new code assessments).
  • Environmental monitoring and microbiology related validations including facilities related.
  • Update of SOP's and CQP’s in relation to environmental testing and microbiology
  • Performing gap analysis of micro and environmental related documentation such as CQP's, SOP's etc.
  • Documentation and filing of all these procedures.

Education & Qualifications

The person occupying this position requires a science-related degree.

Microbiology/laboratory techniques and experience working in a microbiology lab is considered an asset.

Reasonable Accommodations

Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to [email protected] 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.

074241

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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