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Production Operations Coordinator - Night Shift at Xellia Pharmaceuticals USA, LLC

Production Operations Coordinator - Night Shift

Xellia Pharmaceuticals USA, LLC Cleveland, OH Full-Time
Would you like to join an award winning organization that is dedicated to saving lives?

In 2019, Xellia Pharmaceuticals was recognized by the Business Culture Awards as an organization that has impacted its culture through transformative initiatives. Focused on building a sustainable environment through company values and a leadership promise to its employees. Our people make us what we are. We aim to attract the most talented, passionate employees in our industry and to earn their loyalty and commitment. We support our employees through comprehensive people resources processes ensuring that every employee is treated fairly and has a voice which is listened to and valued.

Is that you? If so, we want to learn more about you!

Our Bedford, OH facility is seeking an Operations Coordinator who is responsible for providing coordination and administrative support to the Operations organization. The Coordinator is a role model for quality and culture within the Operations department and drives day to day operations and activities in order to help meet key performance objectives. Assists in tracking metrics for the department and carries out new tasks with limited direction. This position strives to monitor changes in processes, revise documentation, and communicate to appropriate production areas.

Key Responsibilities

  • Provides assistance for Operations area schedule and expediting coordination as necessary.
  • Communicates with appropriate resources to schedule and facilitate required meetings, training, and events inter- and intra-departmentally.
  • Be proactive, take initiative and make decisions with an awareness of the direct and indirect impact of all actions performed. Involve management when necessary.
  • Escalate issues standing in the way of production meeting quality and output targets to management and cross-functional teams in an open and honest way.
  • Participate in investigations, and execute appropriate approved corrective / preventative actions for Operations-related processes. Lead investigations and root cause analysis, where appropriate.
  • Drive continuous improvement in departmental processes. Support collection, presentation, and evaluation of process metrics. Develop and maintain visual display of process metrics to support analysis and identification of improvement opportunities.
  • Maintains the department's library of documents and important office records in a robust and organized manner in order to ensure that future reference is possible.
  • Assemble batch relevant documentation to support the production process. Perform real-time and post-batch review of documentation ensuring compliance with Good Documentation Practices (GDP), production procedures, and escalating issues as appropriate for resolution.
  • Ability to review, revise, and provide input in drafting SOPs relative to the positions within the department.
  • Responsible for execution and completion of individual training per required curriculum and ability to train new/less experienced employees.
  • Performs additional duties and responsibilities as assigned.
  • Ability and drive to build knowledge and understanding of regulatory requirements such as 21CFR part 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies.
  • Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.

Experience and Skills

  • High School Diploma or GED, Associate's degree is preferred
  • Demonstrated ability to effectively communicate cross-functionally both orally and in writing
  • 1-3 years of related work experience in a regulated environment preferred
  • Superior organizational and multitasking capabilities
  • Able to work effectively with people at all levels of the organization
  • Strong Leadership skills preferred
  • Willingness to work overtime (when required)
  • Knowledge of cGMP requirements preferred
  • Must be able to learn and develop a working knowledge of cGMP's as needed.
  • Ability to clearly read and write English required
  • Knowledge and ability to work in Microsoft Office Programs preferred

We offer a competitive compensation and benefits package with an excellent working environment that is safe and engaging. Leaders are dedicated to your success and support professional and personal growth through various development and training opportunities. If you are looking for a rewarding career, Xellia is the organization for you!

Xellia Pharmaceuticals is owned by Novo Holding A/S and is a specialty pharmaceutical company leading in the development, manufacture and supply of anti-infective treatments. Headquartered in Copenhagen, Denmark, Xellia has global facilities in Europe, North America, and Asia, currently employing over 1700 people. With over 100 years of industry experience in developing last resort treatments for infectious diseases, Xellia is focused on the supply of products which not only save lives, but also improve and enhance patients' quality of life. Together with us, you can help lead the fight against bacterial infections.

Read more about Xellia Pharmaceuticals here

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