Quality Specialist - Night Shift - Weekends
Xellia

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!

The Quality Specialist is responsible for providing quality oversight primarily to Building 24, Ready to Use (RTU) manufacturing and packaging areas to ensure product quality and SOP/GMP compliance at the Cleveland Manufacturing Facility. Works closely with Production personnel to complete batch related Environmental Monitoring, on-the-floor, in process batch record review, resolve all batch related issues or escalate to the Quality Assurance Supervisor as appropriate, and ensure good documentation practices are being followed. The Quality Specialist is someone who may require direct guidance and supervision on a daily basis.

This is a night shfit, weekend position. The hours will be Friday, Saturday, Sunday, 5pm-5am

Key Responsibilities

• The primary focus of the Quality Specialist covers: On Floor oversight in Building 24 Manufacturing and Packaging areas, AQL testing, review of batch records and logbooks, and batch related Environmental Monitoring.
• The secondary focus of the Quality Specialist may cover: On Floor oversight in Building 22 Manufacturing and Packaging areas, AQL testing, review of batch records and logbooks.
• Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP's, FDA, OSHA and other regulatory agencies.
• Required to become glove and gown qualified and maintain qualification.
• Required to become qualified on AQL Visual Inspection and maintain qualification.
• Required to complete OJT for Environmental Monitoring.
• Required to be trained on the Maintenance Work Order system.
• Demonstrates an ability to multitask in a proficient manner.
• Addresses daily quality concerns and questions related to operating and environmental issues and clearly communicates complex issues to Management.
• Provide real time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation.
• Complete line of sight inspections of the physical conditions of the manufacturing support areas and report issues to MQA supervision.
• Equally split time between an office setting and manufacturing areas (CNC and CCA).
• Identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality.
• Perform additional tasks in relation to quality issues as assigned by the Quality Assurance Supervisor.

Requirements:

• Bachelor's Degree or higher (in science related field preferable) with no prior experience, or High School Diploma with minimum of four (4) years ofrelevant experience desired.
• Knowledge of a GMP production facility and/or inspection processes required.
• Ability to critically evaluate and troubleshoot complex problems and articulate clearly to management is essential.
• Well-organized and detailed oriented professional, with strong verbal and written communication skills.
• Quality or Pharmaceutical certifications is a plus.

Physical Requirements of the Role:

Position is exposed to several environments, office, lab, outside, plant floor, etc. Frequently talking and using eye and hand coordination. Occasionally requiring lifting and carrying less than 10 lbs. standing, walking, bending over, and repetitive use of legs are done occasionally.

Any person shown at any time (either by medical examination or supervisory observation) to have an apparent illness or open lesions that may adversely affect the safety or quality of drug products shall be excluded from direct contact with components, drug product containers, closures, in-process materials, and drug products until the condition is corrected or determined by competent medical personnel not to jeopardize the safety or quality of drug products. All personnel shall be instructed to report to supervisory personnel any health conditions that may have an adverse effect on drug products.

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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