Inspection and Packaging Operator

Cleveland, Ohio

This job has expired.

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 Inspection and Packaging Operator who is responsible for execution of all aspects of the IV bag inspection and packaging process which includes, but not limited to, the manual inspection of safe and effective sterile (injectable) pharmaceutical products. Operation of secondary packaging line equipment, labelling, and equipment cleaning. Interacts with Quality, Technical Services, Maintenance, Warehouse Departments, and other departments as required. Ensures that daily production is carried out according to current SOP's ensuring absolute compliance to quality standards. The Operator is responsible for documenting daily production outputs and efficiencies and keeps other stakeholders involved and informed. Challenges during production are documented and resolved by means of various LEAN tools. Collaborates in the training of colleagues.

Key Responsibilities

  • Set-up, operation, and troubleshooting of manufacturing equipment: including (but not limited to) Manual Inspection Booths, Semi-Automated Inspection Machine, Secondary Packaging Machines and ancillary equipment (conveyors, pallet jacks, etc.) within validated parameters and in compliance with cGMP's.
  • Operation of automated equipment through a Human Machine Interface (HMI).
  • Clear and concise written documentation to support GMP activities.
  • Performs line change overs and simple-to-moderate equipment adjustments.
  • Supports the creation and updating of procedures enabling the improvement of quality, compliance, and overall process performance.
  • React to issues on the production line and start up systematic problem-solving enabling colleagues to support root cause analysis.
  • Adhere to cGMP's, SOP's, Batch Record processing steps, and site environmental and safety policies.
  • Support a continuous improvement culture and mind set within the department.
  • Possess strong commitment to quality and compliance. Guide colleagues in the importance of proactive behavior regarding improving the work environment towards zero accidents.
  • Work closely together with quality to solve quality issues as they occur and ensure timely release of products.
  • Responsible for execution and completion of individual Training per required curriculum.
  • Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR Parts 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies.

Experience and Skills

  • High School Diploma or GED; Associates Degree in a natural science or technical curriculum preferred
  • Prior experience in a regulated environment; Pharmaceutical or medical device manufacturing experience preferred
  • Must be able to learn and develop a working knowledge of cGMP's; previous knowledge of cGMP requirements preferred
  • Prior experience with complex high speed packaging equipment
  • Experience with quality control technology including vision, robots or automation preferred
  • Ability to clearly read and write English
  • Demonstrates a strong desire to continuously learn and improve

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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