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Quality Assurance Manager, Engineering

Company: Miltenyi Biotec
Location: Gaithersburg
Posted on: June 25, 2022

Job Description:

At Miltenyi Biotec, 3,000 employees worldwide develop pioneering solutions for biomedical science and the clinical application of cell therapies. Our multidisciplinary team combines excellence in research with the development of innovative products for the treatment of serious diseases.Quality Assurance Manager, EngineeringGaithersburg, MDTasks: As a member of the Miltenyi Biotec team, you will perform and report validation activities on equipment and systems that are used in the manufacture of the vector product for domestic and international markets.You will review and approve cGMP documentation including procedures, validation protocols, reports, development reports and other related documents. Additionally, you will observe critical operations and procedures as they occur, audit documentation, record activities and advise senior management on findings and recommendations related to Quality, Facilities, Engineering and Validation issues. Your responsibilities will also include the development and maintenance of metrics and trending reports for compliance-related activities. As a result of your ability to lead continuous improvement objectives to ensure compliance with government regulations by collaborating with departments and external suppliers regarding quality concerns; participating and/or coordinating compliance assessments of departments, as necessary (GXP, Part 11, etc.) and other compliance activities,you will support the continued success of Miltenyi Biotec as a whole.Among other responsibilities, you will:Review and approve cGMP documentation including procedures, validation protocols, reports, development reports and other related documents.Observe critical operations and procedures as they occur, audit documentation, record activities and advise senior management on findings and recommendations related to Quality, Facilities, Engineering and Validation issues.Develop and maintain metrics and trending reports for compliance-related activities.Lead continuous improvement objectives to ensure compliance with government regulations by collaborating with departments and external suppliers regarding quality concerns; participating and/or coordinating compliance assessments of departments, as necessary (GXP, Part 11, etc.) and other compliance activities.Assess problems, identify solutions, plan and implement necessary change will contribute to the continued success of the company.Requirements:Bachelor's in the life sciences from a four-year college or university; at least 8 years experience in biotech, biological, pharmaceutical or other cGMP-regulated industry with at least 2 years in an engineering, validation or quality assurance role; or a combination of equivalent education and experienceKnowledge of MS Office (incl. Access, Excel, Word, etc.), JMP statistical software, Master Control, PowerPoint and Vision.Please note that this position may require vaccination against COVID-19, unless individual is entitled to reasonable accommodation under applicable law.PHYSICAL DEMANDS:The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.While performing the duties of this job, the employee is regularly required to walk; use hands to finger, handle, or feel; reach wit hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch, or crawl. The employee must occasionally lift and/or move up to 15 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have the ability to handle more than one task at a time and must work at a rapid pace while maintaining attention to detail.WORK ENVIRONMENT:The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. This job is performed in a temperature controlled, handicap-accessible facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in an office environment.Lentigen Technology Inc., a Miltenyi Biotec company, is transforming and progressing. Our culture is one of bold scientific innovation. Join a fresh and collaborative working environment that encourages contribution, innovation, and growth.At Lentigen, we support the development and commercialization of novel treatments for human disease through the utilization of Lentiviral Vectors. We hold this widely recognized and clinically relevant method for delivering genetic materials into cells in order to modulate their function as a core strength of our company. We are scientists, engineers, physicians, support specialists, and more - all dedicated to improving scientific understanding and impacting human lives. At our Gaithersburg campus, we strive to find solutions to both the technical and conceptual barriers to the implementation of gene therapy approaches for the treatment of human disease.Lentigen Technology, Inc. is an EO Employer - M/F/Veteran/Disability/Sexual Orientation/Gender Identity.

Keywords: Miltenyi Biotec, Washington DC , Quality Assurance Manager, Engineering, Executive , Gaithersburg, DC

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