Aseptic Control Process Facilitator- Night Shift- West Chester, OH- Operations

Would you like to apply your expertise to impact the Quality Operations in a company that follows the science and turns ideas into life changing medicines? At AstraZeneca, we are guided in our work by a strong set of values, and we’re resetting expectations of what a bio-pharmaceutical company can be. As the voice of the patient, every batch we certify is a personal stamp of approval. A place to take Quality seriously - we draw findings from others to develop and understand what it takes to drive our modern approach forward. Here you’ll feel empowered to step up, follow the science and evidence to make decisions that put patients first.

Our West Chester Supply Site is a multifaceted 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 and Respiratory. 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.

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 Aseptic Control Senior Process Facilitator.  As a member of QC leadership team the Aseptic Control Process Facilitator will also be responsible for delivering QC and site Quality priorities and initiatives as appropriate.  This includes leading a high performing team of leads and technicians working both of the night shift schedules. The position is primarily Monday through Friday but will be required to be on call weekend nights. 

What you’ll do:

• Develop and maintain a high performing team of Aseptic Control Team Leads and Technicians.

• Train and be able to perform all Environmental Monitoring technician responsibilities (including maintaining aseptic qualification) when needed.

• Accountable for the completion of:

  • Monthly and annual trending

  • EMPQ and related document updates

  • Deviations and investigations related to environmental monitoring process or results

• Review completed production and laboratory documentation (for example: log books) for quality, completeness, and cGMP (Good Manufacturing Practices) compliance.

• Train others on procedures, and/or processes.

• Answer compliance and process questions from others, including regulatory agencies.

• Gather, organize, and communicate operational policies and procedures to employees and partners.

• Lead process improvement activities and teams to meet strategic goals.

• Effectively 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.

• Other duties that support Environmental Monitoring, Operations, or Laboratory processes may be assigned.

Essential for the role:

Minimum Requirements:

• Bachelor of Science in Engineering, Pharmacy, related Science or business.

• Minimum two (2) years’ experience in production or quality control environment.

• Previous supervisory or leadership experience preferred.

• Previous Environmental Monitoring and Aseptic Control experience vital.

• Must possess strong leadership, communication and problem solving skills.

• Knowledge or previous experience in leading technical programs/projects.

• Ability to effectively guide and participate in cross-functional teams.

Preferred Background:

• Experience working in a LEAN manufacturing environment.

• Working knowledge of LDMS or AZDocs, Microsoft applications, SAP, or Trackwise.

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. 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

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.