Aseptic Control Process Facilitator - Operations
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:
The Aseptic Control Process Facilitator is responsible for execution of the environmental monitoring and aseptic control activities in accordance with the site operating strategy and the aseptic strategy as developed by the Principle Microbiologist. This includes leading a team of leads and technicians working a 24/7 shift pattern.
The Aseptic Control Process Facilitator must be willing to work a flexible schedule that allows oversight of all production shifts.
As a responsible leader for the operation, this must be done while maintaining effective employee relations and compliance to cGMP, other regulatory, and SOX requirements, as well as SHE obligations and AstraZeneca standards.
As a member of QC leadership the Aseptic Control Process Facilitator will also be responsible for delivering QC and site Quality priorities and initiatives as appropriate
- Train others on procedures, and/or processes.
- Answer compliance and process questions from others, including regulatory agencies.
- Communicate policies and procedures to employees.
- Gather, organize, and communicate operational information to others.
- Lead process improvement activities and teams to meet strategic goals.
- Communicate priorities and progress to team on a continuing basis.
- Ensure that employees have the tools needed to perform their jobs safely.
- Monitor training of employees to ensure compliance.
Essential for the role:
- Bachelor of Science in Engineering, Pharmacy, related Science or business.
- 5+ years’ experience in production or quality control environment.
Desirable for the role:
- Experience working in a LEAN manufacturing environment
- Working knowledge of LDMS or AZDocs, Microsoft applications, SAP, Trackwise
- Training or experience in environmental monitoring, microbiology, quality control, validation, technology transfer, change control.
- Knowledge or previous experience in managing technical programs/projects
- Strong mechanical, troubleshooting and problem-solving abilities.
- Ability to direct and participate in cross-functional teams.
- Project management skills.
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.
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About Operations https://www.youtube.com/watch?v=gak5Ham8oUw
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 authorisation and employment eligibility verification requirements.