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Quality Assurance Senior Specialist - Environmental Monitoring

Company: Miltenyi Biotec
Location: Sunnyvale
Posted on: August 22, 2019

Job Description:

Quality Assurance Senior Specialist- Environmental Monitoring

Sunnyvale, CA Your Tasks

As a member of the Miltenyi Biotec Quality team, you will have the opportunity to develop, establish, implement and maintain the Site Microbial Contamination Control program for cell therapy products in a GMP environment. You will have the opportunity to provide QA oversight of the Environmental Monitoring program and Aseptic Processing Simulation activities, drive microbial contamination deviations and ensure that the proper CAPAs are effectively implemented. You will also have the opportunity to oversee cleaning and disinfectant qualification, cleaning validation program and drive risk management and change controls. You will work jointly with other units across the site to develop and maintain processes and procedures to ensure appropriate quality oversight while demonstrating compliance with cGMP for the Sunnyvale site's clinical and commercial pipelines. Additionally, you will be responsible for overseeing the validation program for QC Microbiology. The unique duties of this position will consist of coordinating release for final cell-based therapeutic products for clinical applications. Overall, your leadership ability and deep knowledge of quality will champion the continued development of Miltenyi Biotec products and growing success.

Requirements

--- B.S. degree in Microbiology, a scientific discipline or equivalent

--- Minimum of 5 years' progressive experience in Quality Assurance; or equivalent combination of education and experience.

--- Experience in aseptic processing, cell therapy, and FDA inspections

--- Strong knowledge of US and EU pharmaceutical GMPs

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 with hands and arms, talk, and hear. The employee is required to stand; climb or balance and stoop, kneel, crouch. The employee must occasionally lift and/or move up to 25 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception and ability to adjust focus. Must have 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 facility without exposure to extreme hot or cold temperatures. Generally, this job is performed in a sanitized laboratory setting and routinely uses standard medical and research equipment such as centrifuges, biosafety cabinets, microscopes, incubators, pipettes and computers. While performing the duties of this job, the employee is frequently exposed to blood, viruses, bacteria, body fluids and other tissues. Employees entering and leaving the laboratory must wear appropriate clothing and protective equipment. The noise level in the work environment is usually moderate.

Miltenyi Biotec is a company that 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 Miltenyi Biotec Inc., we have developed state of the art manufacturing processes for innovative cellular therapies. We are scientists, engineers, physicians, support specialists, and more- all dedicated to improving scientific understanding and impacting human lives. At our Sunnyvale facility we strive to find solutions to both the technical and conceptual barriers to enable development of cell and gene therapy approaches for the treatment of human disease.

Miltenyi Biotec, Inc. is an EO Employer- M/F/Veteran/Disability/Sexual Orientation/Gender IdentityRequirements


  • Progressive experience in Quality Assurance; or equivalent combination of education and experience.
  • Experience in aseptic processing, cell therapy, and FDA inspections
  • Strong knowledge of US and EU pharmaceutical GMPs

Keywords: Miltenyi Biotec, Cupertino , Quality Assurance Senior Specialist - Environmental Monitoring, Other , Sunnyvale, California

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