Grifols Shared Services North America, Inc Packaging/Labeling Graphic Designer 3 in San Diego, California
For more than 75 years, Grifols has worked to improve the health and well-being of people around the world. We are a global healthcare company that produces essential plasma-derived medicines for patients and provides hospitals and healthcare professionals with the tools, information and services they need to deliver expert medical care.
Headquartered in Barcelona, Spain, Grifols has nearly 18,500 employees in 30 countries. Grifols’ three main divisions - Bioscience, Diagnostic and Hospital - develop, manufacture and market innovative products and services available in more than 100 countries.
A leader in transfusion medicine, the Diagnostic Division is a global business focused on providing innovative solutions to help ensure the safety of the blood and plasma supply, detect human diseases and monitor therapies. The division advances patient care with diagnostic solutions to improve disease detection and management, and simplify laboratory operations.
This position will provide package/labeling/graphic design for new product development, commercial/on-market products, regulatory submissions and tenders, and partner-related changes, other routine document revisions, and administrative services in support of instrument and product labels, specifications, and training materials.
Primary responsibilities for role:
The creation, revision, and control of customer labeling, with a primary focus on documentation control through all phases of the change control process.
Write and edit documents to support Labeling Development in compliance with ISO, cGMP, and FDA guidelines, working within established formats and templates. Document types include: specifications, SOPs, and labels (reagent, box, trays).
Identify areas for improvement (e.g., processes, styles, formats), and execute continuous improvement initiatives.
Maintain a high level of quality, clarity, and consistency for all documents.
Organize and maintain department files, databases, and spreadsheets.
Conduct interviews with subject matter experts or partners in order to gather data and understand scope, requirements, risk mitigations, etc.
Initiate the collaborative review process of draft and redline labeling.
Track documentation through the entire development process while adhering to strict timelines, maintaining revision control, maintaining change lists, and managing reviewers.
Ensure that documentation is accurate, complete, meets specifications, and adheres to standards for quality and style.
Expedite change request consideration and approval processes including coordinating review by stakeholders of project change requests, managing stakeholders and approvers for timely response on change management requests, and maintaining comprehensive change management files and documentation.
Manage translation projects with translation vendor and perform translation reviews for consistent format and layout.
Represent Labeling on core teams and coordinate with project teams to determine project and document requirements.
Keep track of documentation through the entire development process while adhering to timelines, maintaining revision control, maintaining change lists, and managing reviewers.
Knowledge, Skills, and Abilities:
Working knowledge of design programs. Proficiency in Word, Excel, PowerPoint a plus.
Excellent written and oral communication skills, and editorial skills.
Strong self-motivation and ability to work independently and in a team environment.
Strong follow up, organization and prioritization skills.
Excellent attention to detail and high word processing accuracy.
Working knowledge of barcode label printing software and printers.
Strong interpersonal skills; ability to learn new concepts quickly and manage multiple projects at once; comfortable with shifting priorities and schedules.
Experience working in a regulated, ISO or GMP environment. Experience with EDMS and workflows a plus.
Knowledge of documentation process and Good Documentation Practices is preferred.
Prior experience in a biotech or regulated industry is strongly preferred.
4 year degree required; preferably in computer/graphic design
Minimum 2 years of experience in graphic design for product packaging.
Advanced proficiency in Adobe Illustrator, experience must be current and used in a professional setting
Depending on the area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in place of the stated requirements. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.
May occasionally lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight, &/or lift, carry, push, pull or otherwise manipulate objects of a negligible weight frequently or continuously. Sedentary work involves sitting the majority of time. Jobs are sedentary if walking & st&ing are required only occasionally.
Location: [[mfield6]] : [[cust_building]]
Learn more about Grifols at http://www.grifols.com/es/web/international/home
Req ID: 72366
Type: Regular Full-Time
Job Category: Regulatory Affairs