Title: Labeling Design Representative Location: Irvine, CA 92618
Duration: 12 months
Job Description: Role Purpose
Process pre-designed changes by using labeling software.
What does this group do?
We design and release labels, IFUs and other labeling components supporting APM sustaining and new product development projects.
Does the team use any specific technology/software you want us to look out for?
Yes, for designers – CMS (preferred, not a must), Adobe suite, Loftware (preferred not a must), for other roles – experience with lifecycle management systems preferred.
What will a typical workday look like?
Working in a team in a cell-like structure where one team members completes his task and hands over to another, also we start with a morning stand up meeting.
What will the work schedule be? Can any overtime be expected?
Hopefully no OT, but it could happen. Normally 8 hour workday. Mostly from home, but first couple of weeks onsite for training (APM office 17200 Laguna Canyon dr).
Will there be any travel involved? No
What is your top required technical skills? Must haves?
Adobe suite for designers, The usual standard office suite for others.
What are core skills to target?
Attention to details, passion for quality, preferred to have experience in a regulated environment (if not med device or pharma, then other good sectors are finance or aerospace).
Job Functions
Essential Job Functions
% of Time Execute complex designed labeling changes (e.g., illustrations), using SDL and Loftware solutions. 65% Evaluate risks, provide recommendations to management and take actions as necessary. 10% Recommend process improvement opportunities that impact procedural updates and take actions as necessary 5% Provide training and coaching to other design team members 5% Support tasks related to Client and CAPA activities 5% Collaborate with labeling cross functional teams to design sustaining labeling changes. 5%
Marginal Job Functions
Percentage Other incidental duties 5%
Qualifications Education/Experience Education Level Field of Study With Years of Experience Details Required Preferred Associate's Degree or equivalent ? 4 years of related work experience X or H.S. Diploma or equivalent ? 6 years of related work experience X
Licenses and Certifications Enter Licenses/Certifications Lic/Certification Details Time Frame Required Preferred
Required Skills Good computer skills including usage of MS Office Suite Good knowledge of labeling design software (e.g., InDesign, Adobe Photoshop, Adobe Illustrator) required; CMS (Content Management System), Loftware Spectrum preferred Good written and verbal communication skills and interpersonal relationship skills Good time management and organizational skills Ability to identify process improvement activities Able to read, comprehend, write, and speak English Full knowledge and understanding of policies, procedures, and requirements as it relates to task execution within labeling design Good knowledge of labeling requirements across business units Full knowledge of labeling systems and applications (e.g., ECR and PDM processes) Strict attention to detail Must be able to work in a team environment, including inter-departmental teams and other business units, under general supervision Provide feedback in a professional, direct, and tactful manner Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
Additional Information Close and continuing supervision Little or no authority to deviate from established procedures Unusual questions are handed off to the supervisor to address and handle (as opposed to the employee continuing to have responsibility) Events not covered by procedures/instructions are referred to supervisor for disposition (as opposed to the employee continuing to have responsibility) Supervisor reviews progress and results for thoroughness
Education and Experience: Bachelor's Degree or equivalent Experience in medical/pharmaceutical FDA regulated industry required 2-4 years of experience required
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