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CQA Specialist (f/m/d) Warehouse and Distribution (Maternity Cover - 24 Months in part-time)

Req #: JR - 029049 Location Höchstadt an der Aisch, Bavaria, Germany Job Category: Quality Control Date Posted: 03/16/2021

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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CQA Specialist (f/m/d) Warehouse and Distribution (Maternity Cover - 24 Months in part-time)

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 CQA Specialist Warehouse and Distribution is responsible for support of the Responsible Person (QP) for Baxter Deutschland GmbH in Höchstadt in following tasks:

  • Perform checks of transport conditions and releases accordingly
  • Execute approvals, releases, holds and other bookings in ERP systems
  • Prepare, check and ship investigation samples for official batch release by the authorities
  • Ensure proper validation / calibration of equipment with respect to GDP
  • Support the local team in QA questions, deviation management, complaints and projects
  • Ensure, that appropriate contacts with country Regulatory Affairs, Vigilance, W&D and Businesses are maintained.
  • Support CAPA and NCR management

ESSENTIAL DUTIES AND RESPONSIBILITIES

The job holder supports the Responsible Person (QP) for Baxter Deutschland GmbH in Höchstadt a. d. Aisch and performs the following tasks:

  • Ensure Good Distribution Practices (Ensure appropriate storage- and delivery conditions)
  • Check returns for compliance to legal requirements, decide on further disposition (for medical devices), or provide data to QP for decision (for drugs)
  • Release products for distribution in Germany after verification they comply with all applicable requirements, where applicable (in cooperation with the manufacturing plant, after review of temperature documentation or release by the local authority e.g. PEI)
  • local Hold Coordinator
  • Execute FA related activities at warehouse level (Implementation of dispositions)
  • Support the local team in QA-related questions, delivery-complaints and projects
  • Support preparation and shipment of demonstration samples for CQA, RA or Marketing

Compliance W&D:

  • Support implement of Good Distribution Practice in the warehouse Höchstadt
  • Support of the CQA-team, warehouse Höchstadt team and Regulatory Affairs team in label checks
  • Regularly inventory and quality check on broken cartons products
  • Performing quality decisions regarding Replenishment complaints
  • Support Replenishment shipments regarding temperature control
  • Check monthly temperature monitoring data of warehouse
  • Perform internal checks and internal Assessments, including validation status, Pest Control results, calibration, maintenance, logbooks and discard of expired material
  • Perform frequent checks on additional client information included in the deliveries

Ensure JDE and WMS (Swisslog) related processes and procedures:

  • Performing and documenting temperature-releases in the warehouse Höchstadt
  • Clarification of deviations during receiving of products and missing receivings with the plants, logistics and CQA
  • Release and bookings in WMS (Swisslog),
  • Check of receipt documentation received from dedicated warehouse worker
  • Manage QC-status in WMS (Swisslog)
  • Correction and bookings in JDE

Support release products for distribution in Germany:

  • Preparation, checking and shipment of samples to Paul Ehrlich Institut (PEI) in close collaboration with the QP.

JOB REQUIREMENTS

Education

The function requires a science degree and previous experience in a pharmaceutical company, QA function preferred.

Experience

Number of years of experience:

  • 2 to 5 years
  • Field of expertise: Preferably in pharmaceutical – quality, production or distribution.

Functional/specific competencies

  • Excellent interpersonal and communication skills
  • Ability to liaise with the different functions involved
  • Excellent ability to coordinate and prioritize work

Languages:

Germant and English fluent, any other additional language would be 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.

029049

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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