Quality Training Coordinator
Xellia

Job Info

---

The Quality Training Coordinator is part of the Compliance Quality Assurance (CQA) department and is responsible for performing administrative tasks related to training and documentation handling at the Xellia Cleveland site. This position will primarily focus on training related tasks (75%), but will also support other CQA managed processes (25%). The Quality Training Coordinator will work in conjunction with Operations Training to perform data entry tasks, scheduling of training, and general coordination of training activities within the Learning Management System (LMS). The position holder must be action oriented; results driven and have a high attention to detail and accuracy.

Key Responsibilities - Training (75%)

• Primary LMS Administrator for Cleveland site Quality departments (CQA, MQA, QC, EM)
• Arranges training assignment of myProcess documents in LMS (Learning Management System).
• System manager for Quality functions Training curricula in LMS.
• Coordinates maintenance of local Quality training material to ensure alignment with global processes.
• Supports the design and implementation of local training materials.
• Prepares trend reports related to training compliance for Quality departments and/or the entire site.
• Manage and maintain hard-copy training records in controlled document storage on site
• Maintain supply of educational aids and training materials
• Author, review the Site Training SOP's in alignment with Global Training Procedures
• The coordinator will support other departments as instructed, in conjunction with the Operations Training Coordinator
• Shared responsibilities (with Operations Training coordinator / specialist) - Perform NEO (New Employee Orientation) Trainings as needed.

Key Responsibilities - CQA (25%)

• Act as a back up to myProcess Document Coordinator and Super User, providing user support when required
• Ensure that critical documentation is created, reviewed, approved, and filed in accordance with company and regulatory requirements.
• Ensure compliance to Good Documentation Practices and provide coaching as needed
• Liaise with all functional groups within the facility to assist in the creation, tracking and control of documents to ensure consistency within the document control system.
• Manage hard copies (controlled copies) as myProcess Privileged User: issue and retrieve copies upon request.
• Perform additional functions as required as deemed necessary by supervisory management.

Requirements

• Knowledge of Quality and cGMP regulations (21 CFR part 210, 211 and Part 11) for Pharmaceuticals
• Advanced organizational skills with the ability to handle multiple assignments.
• Knowledge of Learning Management system and web delivery tools including e-learning platform
• MS Office proficiency
• Excellent written and oral skills.
• Strong interpersonal skills and ability to work effectively with people at all levels

Education / Experience

• Required: High school Diploma / Degree in science
• Minimum 2+ Years' Experience with Training and working in GMP Environment preferable in Pharmaceutical Industry
• Computer skills - Proficiency in MS Office and IT Software's uses in Pharma, LMS

Physical Requirements of the role (list physical requirements, required PPE, etc or N/A this section) .Position is exposed to a number of environments, office, lab, outside, plant floor, etc. This role iscontinuously sitting and typing. Frequently talking and using eye and hand coordination.Occasionally requiring lifting and carrying less than 10 lbs. Standing, walking, bending over, andrepetitive use of legs are done occasionally

Xellia Pharmaceuticals is a specialty pharmaceutical company developing, manufacturing and commercializing anti-infective treatments against serious and often life-threatening bacterial and fungal infections. Headquartered in Copenhagen, Denmark, Xellia has a global footprint with R&D, manufacturing and commercial operations across Europe, Asia, the Middle East and North America. Xellia is wholly owned by Novo Holdings A/S and employs a dedicated team of over 1,800 people.
With over 115 years of experience, Xellia is a world-leading trusted supplier of several important established anti-infective drugs, comprising active pharmaceutical ingredients as well as injectable products. Continuing the Company's evolution, Xellia is generating an innovative pipeline of value-added anti-infective medicines intended to enhance patient care, providing convenience and ease of use for healthcare professionals.
Together you can help us lead the fight against infections.

Further information about Xellia can be found at: www.xellia.com
Connect with us on LinkedIn

This job has expired.