Labeling Specialist - Medical Devices
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
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 adherance 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
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
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.
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
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 adherance 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
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
All qualified applicants will receive consideration for employment without regard to race, color, national origin, age, ancestry, religion, sex, sexual orientation, gender identity, gender expression, marital status, disability, medical condition, genetic information, pregnancy, or military or veteran status. We consider all qualified applicants, including those with criminal histories, in a manner consistent with state and local laws, including the California Fair Chance Act, City of Los Angeles' Fair Chance Initiative for Hiring Ordinance, and Los Angeles County Fair Chance Ordinance. For unincorporated Los Angeles county, to the extent our customers require a background check for certain positions, the Company faces a significant risk to its business operations and business reputation unless a review of criminal history is conducted for those specific job positions.