Manufacturing Quality Assurance Technician Xellia Pharmaceuticals 11 reviews - Cleveland, OH Manufacturing Quality Assurance Technician Quality Position Summary The MQA Technician 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. The MQA Tech works closely with Operations personnel and Environmental Monitoring Technicians to complete on-the-floor audits and training of behavior and technique. The MQA Tech will also work with Operations personnel to perform in-process batch record review and assure good documentation practices are being followed. The MQA Tech will be expected to recommend corrective actions and process improvements to reduce the potential for deviations. The individual holding the position of MQA Technician shall be responsible for the timely review and correction of documentation associated with the operations batch record. This person will also be responsible for assisting in actions associated with environmental issues, placing batches on hold and communicating with Operations the status of production batches. Key Responsibilities * Follows all regulatory guidelines, cGMP guidelines, Environmental Health and Safety regulations as required by the job function. * Works to create an environment of open communication, participation and information-sharing within and between teams within Quality, Operations and throughout facility. * Supports the development of a climate of quality and safety within the teams, by identifying and monitoring quality and safety standards. * Required to be on the manufacturing and/or packaging floor to provide quality oversight for all manufacturing and packaging processes. * Make routine decisions regarding quality related concerns or issues, using good judgement to know when to escalate more complex issues to management/specialist. * Demonstrate a proficient knowledge of the manufacturing process and site procedures. * Attend daily Operations meeting and address any quality concerns and questions related to Operations. * Clearly communicates issues to Management personnel. * Observes and evaluates the manufacturing and packaging areas for improvements that will reduce the potential for deviations. * Complete and maintain high level gowning qualification to enter the Aseptic Core.

• Ensure that deviations are initiated according to procedure. * Assist in analysis of inspection rejects; assist in root cause analysis and implementation of CAPAs. * Perform AQL checks on product when necessary and maintain AQL qualification status. * Perform periodic audits of the manufacturing and support areas observing physical conditions. Provide a report for these audits. * Ensure that current procedures are followed in connection with manufacturing, packaging and environmental monitoring. * Participate in gathering of data needed for the Annual Product Report * Evaluation of operations batch documentation for release. * Elevate non-conforming batch documentation to the proper level of management. * Participate in system, manufacturing and line audits, as required. * Review and update SOPs for GMP compliance. * Track and assist with operations related investigations for deviations.
• Assumes additional duties and responsibilities as assigned. * 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, cGMPs, 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. This may include gowning qualification required to enter the A/B areas. REQUIREMENTS * High School Diploma or equivalent required. College degree preferred in a Science discipline or equivalent. * Must demonstrate ability interpret laboratory data correctly when comparing results to specifications. * Acutely detail-oriented with strong written and verbal communication skills. * Demonstrated ability to follow detailed directions. * Must be familiar with Microsoft Office applications, including Word and Excel. * Ability to comprehend and adhere to site SOPs and cGMPs related to the role and work areas that will be supported. * Work effectively wearing all required clean clothing and PPE such as head, face, hand and arm coverings to include goggles and full body suits. * One year relevant experience in a GMP manufacturing environment preferred. * Familiarity with cGMP requirements, manufacturing, machine operations, process flow, laboratory operations, and data entry preferred. Physical Requirements of the Role Must be able to frequently stand, bend over, and walk around sterile environment. Occasionally crawling, climbing, reaching, crouching, kneeling, pushing and pulling. Repetitive motions with hands, arms, and legs, as well as frequently lift 10-25 lbs. Also must be able to carry 10-25 frequently. Fine manipulation of small instruments is required. 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. 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. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this job. Employees holding this position will be required to perform any other job-related duties as requested by management. All requirements are subject to possible modification to reasonably accommodate individuals with a disability. 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 9 hours ago - save job - original job Apply On Company Site Other jobs you may like Quality Assurance Technician Octapharma Plasma, Inc. - Cleveland, OH 9 days ago Quality Assurance Quality Control Technician... 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