Control Specialist I

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.

Essential Duties and Responsibilities

Artwork Control:

• Perform labeling quality control of Design artworks to ensure accuracy and compliance to approved inputs including artwork redlines (markup), templates and specifications.
• Ensure all typesetting of packaging components (including the text, graphics, chemical structures, bar codes etc…) are as per guidelines and standard.
• Be proficient in using the approved proofreading application to ensure that Design artworks are updated correctly per approved inputs.
• Perform technical review of labeling specifications to approved inputs including specification redlines, templates or other applicable technical inputs
• Proper Storage and archiving of documents as per local procedure.

Document Control

• Trained in GDP, ability to maintain clear traceability with multiple revisions & multiple sign offs.
• Work with labelling operations to finalize markups. Ensure that documentation is in line with EU/FDA Regulations.
• Process labeling documentation in Baxter’s System of Record, including setting up workflows, sending for approvals and documentation release.
• Ensure labeling documentation is processed, approved and filed per labeling and documentation (retention) procedures.

General Duties and Responsibilities.

• Ability to support and drive business targets associated with the labeling operations team (cycle time, accuracy, compliance).
• Input accurate data into labeling team tracking systems and spreadsheets.
• Ability to support Global facilities/entities.
• Ensure to maintain a 6S working environment in the working area.
• When required, the incumbent shall provide support on project improvements.
• The incumbent is also responsible to ensure that all procedures related to his/her responsibilities are in line with corporate requirements and that any corrective actions triggered by Corporate/Internal/Other audits are always implemented within the established time frames.
• The incumbent is also responsible to consider the aspects of Environment Health and Safety procedures to ensure that all activities within the role will support EHS targets and will not jeopardize the health and safety of employees and environment.
• The incumbent must also ensure that all documentation and practices related to the role are comply with good documentation practices.

Qualifications

• Experience of performing design control and document proof reading in accordance to ISO standards.
• Exceptional organizational skills and ability to support business targets.
• Experience in using IT Process Oriented Systems
• Experienced in using “Global Vision” or similar proofreading software.
• Be meticulous and attentive to detail.
• Experience in quality control would be considered an asset.
• Good interpersonal and communication skills.
• Fluent in English (both written and verbal).
• Fluency in any other language is considered as an asset.

Education and/or experience

• Diploma or Advanced level of education is essential. Must be ICT proficient user.
• Or 1 to 3 years’ experience working in the quality control department.

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.