AstraZeneca Pharmaceuticals LP Packing Documentation Change Specialist - (Mount Vernon, IN) in Mount Vernon, Indiana
At AstraZeneca we turn ideas into life changing medicines. Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. We’re focused on the potential of science to address the unmet needs of patients around the world. We commit to those areas where we think we can really change the course of medicine and bring big new ideas to life.
As a Packing Documentation Change Specialist in Mt. Vernon, IN, you’ll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients’ lives. Operations at AstraZeneca is a truly world-class business unit. It offers one of the most exciting, fast paced, challenging and rewarding work environments in the world of operations, supply chain and manufacturing.
The Packing Documentation Change Specialist is responsible for delivering the packing documentation change processes for the US Mount Vernon Pack Site, 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.
You will provide 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.
You will serve 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).
You will serve as ROBAR System Administrator including setup of formats and records.
You will hold routine Job Tracking communication meetings with key assigned customers. You will maintain Job Tracking Information for assigned jobs, including maintaining a forward view of upcoming changes.
You will maintain packaging artwork, packaging specifications, specification drawing files, and database within the appropriate systems. You will ship approved documentation to approved vendors/suppliers as needed.
You will interface with external artwork vendors to coordinate all artwork changes in alignment with project and regulatory timelines.
You will lead cross-site initiatives to standardize workflows and agrees on processes with internal and external customers.
You will lead or support packing documentation related projects.
You will initiate Change Request (CR) and Labeling Request (LRF) forms for packing documentation changes.
You will lead or participate in interdepartmental and intercompany project teams.
You will review and comment on CR’s and LRF’s as necessary.
You will coordinate workflow with other sites.
You will support internal, external, and regulatory inspections.
You will participate in the investigation and resolution of product quality problems.
You will execute work in compliance with GMPs, site policies, work instructions, and SOPs.
You will work in partnership with site SHE to ensure work is in compliance with environmental and safety regulatory standards.
You will maintain a safe work environment and follows site SHE policies and procedures.
The incumbent is not necessarily performing all the Major Responsibilities of the role immediately. The incumbent may begin by specializing in one or more of these responsibilities whilst working to develop a solid knowledge of the process being supported and applicable cGMPs. Over time the incumbent will be expected to obtain the necessary training to become skilled in all major responsibilities of the role.
Capability focus will be in 3 main areas; AZ Supply Chain, AZ professional & AZ core. Individuals are required to work within and demonstrate each of these.
Bachelor’s degree or 10 years of relevant industry experience.
Minimum 5 years of 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.
Bachelor’s degree, preferably within a technical or scientific field.
1-3 years of 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.
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.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.