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Process Coordinator, Packaging- Operations, West Chester, Ohio

CountryUnited States
CityWest Chester
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.

Our West Chester Supply Site is a very dynamic and growing manufacturing site within the AstraZeneca Global Operations network and is located just north of Cincinnati, Ohio. In addition to serving as the global COVID vaccine production site for AstraZeneca, the West Chester site encompasses Bulk API Microsphere manufacturing, Aseptic Pharmaceutical Formulation, multi-line Isolator/Barrier Vial and Syringe Filling, and specialty Packaging Operations for Vials and Auto-Injectors that supports growing franchises in Diabetes, Respiratory, and Vaccines. Our site is one of 30 production facilities in 18 countries with over 700 people collaborating to connect powerful medications to patients in more than 60 countries around the world. We focus on providing a collaborative environment where everyone feels comfortable and able to be themselves. Being able to bring your full self to work every day is at the core of AstraZeneca's priorities. On-site amenities include a Health and Wellness clinic, as well as a Cafeteria Grille serving breakfast and lunch items for employees and guests. We also have a Great Place to Work Counsel, involving committees of employees who coordinate several activities related to community outreach, sustainability, health and wellness and social events

What you'll do:

Performs tasks in support of the pharmaceutical manufacturing processes in Manufacturing. Specific requirements include assisting with manufacturing investigations; issuance, revision, and authoring of documents; maintaining team production metrics for shift. The position provides oversight, execution, and approval for transactions in SAP, KRONOS and Trackwise as well as ensuring that OEE performance data is collected as specified for each operating area.
  • Review time entries and make necessary adjustments in the Kronos system.
  • Maintain an advanced knowledge of the SAP system and execute SAP transactions as required to complete process orders.
  • Daily and weekly coordination of activities to ensure production schedule is met.
  • Technical writing to include investigations, line assessments, and corrective actions.
  • Create, revise, and assist with preparation of documentation regarding activities, actions, and/or results using GDP where applicable.
  • Communicate policies and procedures to employees.
  • Establish visual tracking and other tools to enhance Audit readiness and trend analysis.
  • Guide team on SOPs (Standard Operating Procedures), work instructions, and MBRs (Master Batch Records).
  • Lead training on all document modifications prior to effective date.
  • Initiate appropriate action when process deviations occur via Trackwise IDM. Report process deviations when they occur.
  • Investigate manufacturing deviations; close out deviations, CAPAs and/or pAFCAs as needed.
  • Review completed production documentation (for example: batch records, log books, and so on) for quality, completeness, and cGMP compliance.

Essential for the role:
  • Experience in documentation in a cGMP environment
  • High school graduate, vocational school graduate or equivalent
  • 3 Years of experience in a pharmaceutical or cGMP regulated environment

Desirable for the role:
  • Bachelor's degree or equivalent
  • Experience working in a LEAN manufacturing environment
  • Knowledge of cGMPs and FDA policies/procedures

Why AstraZeneca?

At AstraZeneca when we see an opportunity for change, we seize it and make it happen, because any opportunity no matter how small, can be the start of something big. Delivering life-changing medicines is about being entrepreneurial -finding those moments and recognizing their potential. Join us on our journey of building a new kind of organization to reset expectations of what a bio-pharmaceutical company can be. This means we're opening new ways to work, pioneering cutting edge methods and bringing unexpected teams together. Interested? Come and join our journey!

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.

Find out more on Social Media:

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About Operations https://www.youtube.com/watch?v=gak5Ham8oUw