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Sr Labeling Specialist CA

1 month ago

Irvine, United States Talentburst Full time

Position: Sr Labeling Specialist, Req#: 9059-1

Is this the role you are looking for If so read on for more details, and make sure to apply today.
Location: Irvine, CA (Mostly from home, but the first couple of weeks onsite for training in the Irvine, CA office).
Duration: 12+ Months Contract (with the high possibility of extension.)

More on this role:

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 will a typical workday look like?

Working in a team in a cell-like structure where one team member completes his task and hands it 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 the first couple of weeks onsite for training in the Irvine, CA office.

What are your top required technical skills? Must haves?

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

Job Description:

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

Education and Experience:

  • Associate's Degree or equivalent (e.g., 2 years of college coursework) with 4 years of related work experience or H.S. Diploma or equivalent 6 years of related work experience
  • 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 they relate 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 the environment and prevent pollution under their span of influence/control

Key Responsibilities:

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 a 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 75%
  • Evaluate routine risks and provide recommendations to resolve issues. 10%
  • Update more complex procedures and lead routine process improvement opportunities within the scope 5%
  • Provide training and coaching to other team members 5%

Marginal Job Functions:

  • Other incidental duties 5%

Level of Independence:

  • 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 the supervisor for disposition (as opposed to the employee continuing to have responsibility)
  • Supervisor reviews progress and results for thoroughness
  • People Management

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