Quality Label Project Coordinator
Posted on: June 25, 2022
OUR NEED:Responsible for coordination of all printed materials
labeling deliverables (will vary by project), including labels,
inserts, and cartons. These include but are not limited to label
part number generation and approval of artwork per regulatory
guidelines. Develop deliverable schedules and establish milestones
for tracking progress. Interacts with internal cross-functional
teams to provide input into labeling projects. Engages the global
labeling group to meet company goals including label introduction
and label improvement projects. Responsible for change control task
closures and preliminary assessments. May participate in other
documentation and label control roles.YOUR RESPONSIBILITIES:1.
Responsible for the management of all documentation related to new
labeling introduction and label revisions.
2. Coordinate and track the status of new/revised labeling
following manufacturing planning schedule.
3. Provide editorial support and ensure quality of all document
content; focus on clarity, accuracy, and consistency, while
maintaining adherence to proper formats, regulatory requirement and
company procedures and guidelines. Create, draft and revise SOP's
and manufacturing batch records related to label changes.
4. Collaborate with cross-functional departments to ensure timely
implementation of document change controls and requests.
5. Support tracking and communication of site metrics to
6. Implement initiatives to enhance the labeling revision process
7. Accountable for entry of document-related information into
applicable logs, both manual and electronic for tracking and
accountability purposes. Assure that any data tracking systems are
kept current and are operating as efficiently as possible.
8. Assist in special projects, complete project tasks to
effectively meet with project timelines.
9. Self-motivated, proactive, detail-oriented, and able to manage
multiple tasks while still meeting deadlines.
10. Ability to successfully handle multiple competing priorities in
a fast-paced, changing team environment.YOUR PROFILE:
- Bachelor's degree
- 2-3+ years in a pharma manufacturing GMP environment
- Excellent written and oral communication skills, detail
- Strong analytical, organizational and CS service skills
- Outstanding technical writing, structural and project
- Knowledge and experience in understanding regulations and
guidelines of FDA, CFR, ICH, cGMP, and GDP pharma industry
Keywords: Guerbet, Raleigh , Quality Label Project Coordinator, Other , Raleigh, North Carolina
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