The Manufacturing Quality Assurance Supervisor is responsible for daily management of quality assurance operations at the Xellia Cleveland site. The MQA Supervisor will manage the daily tasks for the applicable shift to support the manufacturing operation. 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. Has knowledge of Quality Assurance and Control in general and the Quality Management System (QMS) in compliance with 21CFR part 11/210/211 specifically, and requires some minimal coaching when making critical quality decisions.
This role will be for weekend coverage. The shift will be Friday, Saturday, Sunday 8am-8pm
- Supervise, develop, manage and train personnel in MQA
- 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
- Responsible for the authorization of SOP's and/or qualification/validation documents
- Assist with deviations including scope, impact and associated corrective actions
- Participation in Change Control committee, evaluation and authorization of change controls
- Ensure that direct reports are current on all required training
- Collecting and reporting data for the monthly Site Governance Meeting
- Perform additional tasks in relation to quality issues as agreed with the MQA Manager
- Manage and escalate Quality issues to the MQA Manager
Physical Requirements of the Role
- B.S. in Physical Science or Engineering (or equivalent) with a minimum of 3 years industry experience
- A good knowledge of various GMP compliances regulations and industry practices
Ability to critically evaluate and troubleshoot complex problems is essential
- Ability to effectively participate on multi-disciplinary teams
- 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
Position is exposed to a number of environments, office, lab, outside, plant floor, etc. This role is continuously sitting and typing. 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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