Manufacturing Quality Assurance Supervisor - Weekends
Xellia

Job Info

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The Manufacturing Quality Assurance Supervisor is responsible for the daily management of manufacturing Quality assurance at the Xellia Cleveland site. The MQA Supervisor manages the daily tasks for the applicable shift to support manufacturing operations. The areas of responsibility for the MQA Supervisor are: On the floor Quality oversight, batch record review, logbook review, review and approval of work orders and identification of deviations. This includes collaboration, development, implementation and management of quality assurance processes, procedures, and best practices. The MQA Supervisor has knowledge of Quality Assurance and Quality Control and the Quality Management System (QMS) in compliance with 21CFR part 11/210/211 and requires minimal coaching when making critical quality decisions.

This position will work weekends, Saturday, Sunday and Monday Hours will be roughly 8:00am-8:00pm. Can be flexible, but will need to cover both shifts.

Key Responsibilities

• Supervise, develop, manage, and train MQA personnel.
• Supervises the day-to-day activities of the EM team.
• Quality oversight of the manufacturing areas including batch record review, logbook review, general condition of the controlled areas and monitoring of cleanroom behaviors.
• Responsible for personnel management including hiring, development, and performance management.
• Quality Oversight for the calibration and maintenance system.
• Review of executed protocols for Good Documentation Practices.
• Responsible for the authorization of SOP's and/or qualification/validation documents.
• Quality oversight of deviations including scope, impact, root cause, and associated corrective actions.
• Participation in Change Controls and CAPA development.
• Ensure that direct reports are current on all required training.
• Perform additional tasks in relation to quality issues as agreed with the MQA Manager.
• Manage and escalate Quality issues to the MQA Manager/Senior Manager.

Qualifications

• B.S. in Physical Science or Engineering (or equivalent) with a minimum of three (3) years industry experience.
• A good knowledge of various GMP regulations and industry practices.
• The ability to critically evaluate and troubleshoot complex problems is essential.
• The ability to effectively participate on multi-disciplinary teams.
• The ability to absorb, digest and relate detailed scientific, quality, and regulatory information.
• Well-organized and detailed oriented professional, with strong verbal and written communication skills

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 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
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