At AstraZeneca we work together across global boundaries to make an impact and find answers to challenges. We do this with the upmost integrity even in the most difficult situations because we are committed to doing the right thing. We continuously forge partnerships that help pursue world-class medicines in new ways, combining our people’s exceptional skills with those of people from all over the globe.

The Packing Documentation Change Specialist is responsible for delivering the packing documentation change processes, including changes to packaging specifications, packaging artwork, spec drawings, and the links to the materials creation process. They will independently manage assigned packing documentation change jobs to meet needs of key internal/external customers including the site production PET’s, Regulatory Affairs, project teams, vendors, and contractors

Job Responsibilities:

Operations

• Provides primary support and coordination for packaging documentation changes at MTV. This includes changes to packaging artwork, packaging specifications, packaging specification drawings/templates, and Bill of Material (BOM) change initiation forms.
• Serves as project manager for packing documentation changes from initial notification to implementation to ensure sufficient time is available to implement the change to meet customer timelines (either internal or external).
• Serves as ROBAR System Administrator including setup of formats and records.
• Holds routine Job Tracking communication meetings with key assigned customers. Maintains Job Tracking Information for assigned jobs, including maintaining a forward view of upcoming changes.
• Maintains packaging artwork, packaging specifications, specification drawing files, and database within the appropriate systems. Ships approved documentation to approved vendors/suppliers as needed.
• Interfaces with external artwork vendors to coordinate all artwork changes in alignment with project and regulatory timelines.
• Leads cross-site initiatives to standardize workflows and agrees on processes with internal and external customers.
• Leads or supports packing documentation related projects.
• Initiates Change Request (CR) and Labelling Request (LRF) forms for packing documentation changes.
• Leads or participates in interdepartmental and intercompany project teams.
• Reviews and comments on CR’s and LRF’s as necessary.
• Coordinates workflow with other sites.
• Work closely with Pack Engineering to address issues raised by print vendor and IMQC related to printed components.
• Coordinate with Third Party Customers by acting as the primary contact for routing, approving, and managing effectivity of packaging documents (i.e., Bill of Specification (BOS) and Shipper Case Label (CSL).

Education, Qualifications, Skills and Experience:

Essential:

• Bachelor’s degree required.
• Minimum 3-5 years experience in one or more of the following areas: Packing Operations, Production Planning, Quality Assurance, Packaging Technical Services, or Packaging Graphics.
• Knowledge and understanding of packaging processes, format development, compliance issues, and cGMPs.
• Experience using personal computers and database computer system applications.
• Strong interpersonal and communication skills with the ability to work across all levels of the company.
• Strong organization skills and ability to support multiple projects simultaneously.
• Demonstrated high-level of attention to detail.
• Strong project management skills and experience.

Desirable:

• 1-3 years experience with packaging.
• Technical Document Management and change management experience.
• Proven ability to work independently and professionally in a GMP-regulated environment.
• Knowledge of the commercial printing process.

Key Relationships to reach solutions:

Internal (to AZ or team)

• Internal functional groups across Site Operations.
• Other AstraZeneca US Operations Sites Quality Assurance functions

External (to AZ)

• Third Party Artwork Vendors or Contractors
• Professional Organization Members (ASQ and/or ISPE, etc.).

Next Steps – Apply today!

To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience – it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.

Date Posted

Closing Date

AstraZeneca embraces diversity and equality of opportunity.  We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills.  We believe that the more inclusive we are, the better our work will be.  We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics.  We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.