Manufacturing Quality Assurance Specialist I
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Quality
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. This individual will 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 while ensuring good documentation practices are being followed. The MQA Specialist I should be someone who may require direct guidance and supervision on a daily basis.
Key Responsibilities
- Required to be on the floor and present to provide quality oversight for all critical manufacturing processes
- Required to become and maintain gown qualification
- Required to become and maintain AQL Visual Inspection Qualification
- Works closely with MQA supervision as needed
- Demonstrates an ability to multitask in a proficient manner
- Addresses daily quality concerns and questions related to operating and environmental issues
- Clearly communicates complex issues to Management personnel
- Work closely with Production personnel to complete in-process batch record review, resolve batch related issues with guidance from MQA Supervision
- Assist in analysis of inspection rejects; assist in root cause analysis and implementation of CAPAs
- Perform and document assessments of aseptic behavior inside the aseptic manufacturing area during filling, capping, and lyophilizer loading/unloading activities. Provide real time aseptic technique coaching and risk mitigation in the event of an aseptic technique violation
- Complete monthly inspections of the physical conditions of the manufacturing support areas and report issues to MQA supervision
- Provide regular updates about aseptic behaviors to the production department, support groups and site leadership
- Participation in gathering of data needed for the Annual Product Review
- Collecting of data for Quality Monthly Report
- Perform additional tasks in relation to quality issues as assigned with the Quality Assurance Supervisor
- Equally split time between under desirable conditions of the office setting and exposure to moderately disagreeable features of noise, heat or production conditions
- Ensure processes and products are in compliance with all local, state, and federal rules and regulations. Oversee that processes are in CGMP compliance, and establish systems that identifies opportunities for improvement and makes constructive suggestions for change to improve process effectiveness to heighten quality. Develop knowledge of and understand regulatory requirements such as 21CFR part 210 and 211, cGMP’s, FDA, OSHA and other regulatory agencies.
- Personnel engaged in the manufacture, processing, packing, or holding of a drug product shall wear clean clothing appropriate for the duties they perform. Protective apparel, such as head, face, hand, and arm coverings, shall be worn as necessary to protect drug products from contamination.
- The primary focus of the MQA Specialist I covers the following areas: On Floor oversight in Manufacturing and Packaging areas, Incoming Material Inspection, Review of batch records and packaging records
Qualifications:
- B.S. in Life or Physical Science with one (1) to five (5) years or equivalent education/professional experience
- 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 a number of 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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Information og data
Denne ledige stilling har jobtypen "Produktchef", og befinder sig i kategorien "Ledelse og personale".
Arbejdsstedet er beliggende i København
Jobbet er oprettet på vores service den 22.11.2021, men kan have været deaktiveret og genaktiveret igen.
- Produktchef
- København
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