1 year contract

What does your group do?

We design and release labels, IFUs and other labeling components supporting APM sustaining and new product development projects.

Does your 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 is your top required technical skills? Must haves?

Adobe suite for designers, The usual standard office suite for others.

Role Purpose

Accountable for ensuring that all work associated with updates or changes to global labeling standards/procedures, training plans and process improvements, routing and approval of assigned labeling deliverables through ECR and PDM processes is carried out in compliance with relevant standards and regulations

Job Functions

Essential Job Functions

• Execute complex label change packages (e.g., ECO, mass updates, redlines, ECR generation and processing, compiling documentation, data entry) within and across all business units/sites with limited to no direction. Summarize and capture change intent accurately within quality system (e.g., ECR) in adherence to GDP (Good Documentation Practices). Actively follow up on change requests (e.g., SARS, ECRs) and manage approvers to ensure timely closure
• Evaluate routine risks and provide recommendations to resolve issues.
• Update more complex procedures and lead routine process improvement opportunities within scope
• Provide training and coaching to other team members

Qualifications

Education/Experience

Associate's degree or equivalent (e.g., 2 years of college coursework) 4 years of related work experience or

H.S. Diploma or equivalent with 6 years of related work experience

Required Skills

• Good computer skills including usage of MS Office Suite

• 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 operations

• 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