Manufacturing Quality Assurance Specialist I - 3rd Shift
Xellia

The MQA Specialist I is responsible for providing quality oversight to all manufacturing and packaging areas to ensure product quality and SOP/GMP compliance at the Cleveland Manufacturing Facility. Works closely with Production personnel to complete 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 MQA Specialist I is someone who may require direct guidance and supervision on a daily basis.

Key Responsibilites:

• The primary focus of the MQA Specialist I covers the following areas: On Floor oversight in Manufacturing and Packaging areas, Review of batch records.
• 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 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'sDegree or higher (in science related field preferable) with no prior experience, or High School Diploma with minimum four (4) years of relevant 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.

Disclaimer:

This job description is intended to describe the general nature and level of work being performed by the person assigned to this position. The primary duties and responsibilities are intended to describe those functions that are essential to the performance of this job. This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Other duties and responsibilities assigned by management are considered incidental or secondary to the overall purpose of this job. Employees holding this position may be required to perform other job-related tasks as requested by management. All requirements are subject to possible modification to reasonably accommodate individuals with a disability.

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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