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Calibration Administrator

Company: Adverum Biotechnologies
Location: Redwood City
Posted on: June 2, 2021

Job Description:

The Calibration Administrator is responsible for scheduling and documenting National Institute of Standards and Technology (NIST) traceable calibrations of all measuring and test equipment related to facilities, production and analytical processes which require routine calibration at the Adverum Biotechnologies facilities in Redwood City California. Key attributes of the successful applicant include the ability to work in a dynamic environment with high expectations and rapid change, experience with development and validation of automated equipment and systems in a regulated facility, and willingness to work as a lead within cross-functional teams.What you'll do:Manage and assist vendors to perform calibration work on complex instruments such as Temperature, Pressure, Electronic, Flow, Weight, Level, Speed, pH & Conductivity, Laboratory Equipment and other manufacturing and utility system instrumentation.Complete calibration work orders and engineering change controls within the allotted time.Maintain all calibration records, work orders, and investigations in an orderly and accurate manner in compliance with cGMP s.Assist Equipment Owners determine the appropriate Calibration Information for their processes through the evaluation of Instrument specifications.Assist in Regulatory and Internal Audits / Inspections.Assist with Off-site Calibration Activities, communicating with Vendors to get calibration quotes, etc., and Interface with calibration contractors, ensuring work is compliant with AGC SOP's and cGMP's within the facility.Assist in the review and development of Calibration Department Procedures.Assist in the development of investigations and initiation of any documentation resulting from 'Out of Tolerance' conditions with respect to instrumentation.Ensure compliance with all applicable regulatory agencies including FDA, OSHA, CFR, etc.Researching calibration standards requirements for laboratory equipment.Help maintain a future equipment calibration and maintenance program software.Verify equipment program schedules monthly.Maintaining procedures, policies, documents for regarding the calibration and preventative maintenance of equipment within a cGMP laboratory.Assist in preventative maintenance scheduling.Other functions as determined by the Facilities Management.Physical Requirements: While performing the duties of this job, the employee is regularly required to:Experience prolonged sitting, standing, walking, bending, stooping, and stretching.Use hand-eye coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and other office equipment is required.Have a normal range of vision, with or without corrective lenses.The ability to regularly lift and/or move up to 45 pounds and occasionally lift and/or move up to 70 pounds briefly.Climb ladders and stairs of various heights.Be exposed to noisy environments.Must be able and willing to maintain a standard 5/40 work schedule, with occasional extended hours/overtime as required to meet surges in activity or other business needs.About you:High school diploma or GED is required.2-3 years of relevant experience Experience within a GMP production facility is preferred, but not required.Strong written, verbal, and interpersonal communications skills.Strong analytical and problem-solving skills and experience applying these skills to resolve technical problems.Strong skills and experience in MS Office products (Word, Excel, Outlook, PowerPoint).Computer literate in computer-based maintenance program desirable.In-depth knowledge of calibration and documentation requirements for cGMP manufacturing.Demonstrated good interpersonal skills, customer focus, and professionalism. About UsAdverum is a clinical-stage gene therapy company targeting unmet medical needs in ophthalmology and rare diseases. Adverum develops gene therapy product candidates designed to provide durable efficacy by inducing sustained expression of a therapeutic protein. Adverum s core capabilities include clinical development, novel vector discovery and in-house manufacturing expertise, specifically in scalable process development, assay development, and current Good Manufacturing Practices quality control.At Adverum, Inclusion and Diversity are at our core. We believe in the power of being your authentic self. We strive to create the space which allows for everyone in our Adverum Community to not only feel safe but encouraged to speak, learn from each other, grow in their professions and be the very best versions of themselves no matter what their age, ethnic background, gender, origin, religion or sexual orientation Associated topics: bioengineer, design, develop, engineer, manufacturing, manufacturing engineer, mechanical, mechanical engineer, process engineer

Keywords: Adverum Biotechnologies, Redwood City , Calibration Administrator, Other , Redwood City, California

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