Role: Sr. Labeling Specialist

Location: Irvine, CA - 92618

Duration: 12 Months

Job Description:

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

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 adherance to GDP (Good Documentation Practices). Actively follow up on change requests (e.g., SARS, ECRs) and manage approvers to ensure timely closure 75%

Evaluate routine risks and provide recommendations to resolve issues. 10%

Update more complex procedures and lead routine process improvement opportunities within scope 5%

Provide training and coaching to other team members 5%

Qualifications:

Education/Experience

Education Level Field of Study With Years of Experience Details Required Preferred

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