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Location:
West Chester, Ohio, United States
Job reference: R-046982
Posted date: Mar. 15, 2019
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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 primary function of the Aseptic Training Facilitator position is to facilitate the AZ WCH sterile manufacturing aseptic training program. The Aseptic Training Facilitator will be responsible for the administration, compliance and delivery of this program as well as facilitation of the Aseptic Training Center from scheduling through content delivery. The facilitator will work with stakeholders on site and around the globe to develop and implement best practices that will improve the aseptic capabilities and compliance of the site while encouraging sharing across the AZ network.

Job Responsibilities

  • Perform necessary assessments of sterile operations, identify areas for improvement, work cross functionally to design and implement process improvements, and update necessary documentation and associated training materials.
  • Facilitate utilization of the on-site training center from scheduling through content delivery and qualification assessments.
  • Work with department leaders to ensure training materials are adequate for the job functions and aligned to department staffing and training plans.
  • Maintain working knowledge of cGMPs and emerging regulatory and compliance concerns as related to sterile manufacturing.
  • Maintenance of LMS system (SABA) training plans, courses, and records for Aseptic Training Programs.
  • Must be able to simplify complex matters and be able to present with clarity, confidence and thoughtfulness.
  • Completes other duties as assigned.

Education, Qualifications, Skills and Experience

Required

  • Bachelor's Degree in a technical field, such as Engineering/Microbiology.
  • 3+ years of experience in an aseptic environment or supporting aseptic manufacturing.
  • Strong oral, written, communication, presentation and interpersonal skills.
  • Ability to facilitate small to large groups through classroom training as well as physical exercises based on the training content and site processes.
  • Ability to assess class participants ability to execute according to training/SOP for qualifications.
  • Must be able to take complex principles and concepts and break them down into teachable elements so colleagues can quickly understand.
  • Must be able and willing to work a flexible schedule and support the training needs of a 24/7 manufacturing site.

Preferred

  • Advanced degree, Masters or higher in Engineering/Microbiology
  • Multiple site or function experience.
  • Training Development Experience.
  • 2+ years of supervisory experience in an aseptic manufacturing environment.

Key Relationships to Reach Solutions

Internal:

  • The Aseptic Training Facilitator, must interact with AZ  corporate personnel, cross-site colleagues, and industry experts to set the direction for the sterile manufacturing training program to drive necessary change.
  • Encompasses responsibility for the implementation of key aseptic/sterile principles, drive accountability and support cGMP requirements in manufacturing. This position requires the incumbent to assess situations in relation to regulatory requirements, site and corporate requirements.

External:

  • Regulatory agencies such as FDA, MHRA, ANVISA, etc.
  • Third Party Contracts (e.g. materials and equipment vendors).

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

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Aseptic Training Facilitator - Global Operations
QA

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