QA Specialist I Document Control (Contract)

United States·Redwood CityContractmid

OtherQa Specialist

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Adverum Biotechnologies, Inc., wholly owned subsidiary of Eli Lilly and Company,

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OtherQa Specialist

Adverum Biotechnologies, Inc., wholly owned subsidiary of Eli Lilly and Company, is a mission-driven clinical-stage company that aims to establish gene therapy as a new standard of care for highly prevalent ocular diseases with the aspiration of developing functional cures to restore vision and prevent blindness. Leveraging the research capabilities of its proprietary intravitreal (IVT) platform, Adverum is developing durable, single-administration therapies designed to be delivered in physicians’ offices to eliminate the need for frequent ocular injections to treat these diseases. By overcoming the challenges associated with current treatment paradigms for these debilitating ocular diseases, Adverum aspires to transform the standard of care, preserve vision, and create a profound societal impact around the globe.

Adverum Biotechnologies is looking for an entry level QA (Document Control) Assistant that is looking to learn more about QA/Document control standards. This individual must possess attention to detail, be a self-starter, have an understanding of various paper filing systems and possess the ability to identify gaps and ask questions.

This is a contract role is designated to be onsite (HQ -Redwood City).

Organize the Document Control Room, labeling shelves, ensuring proper categorization and easy retrieval of the documents.

Filing the executed Test Records by assay and by sequential number.

Filing the completed equipment logbooks

Filing all executed forms issued by QA to QC

Filing all the equipment calibration records

Filing Quarterly Reese reports and GxP material receiving forms

Organizing the equipment IOQ binders

Organizing the training records received before using MasterControl

Create binders with the hard copies of electronic files of Deviations, CAPAs, Change Control and MRBs initiated in 2021,2022 and 2023

Create binders with the hard copies of electronic files of all memorandums issued by QA in 2020, 2021, 2022, and 2023

Conduct reconciliation of QA issued documents, including but not limited to Test record Forms (TRFs), logbooks, lab notebooks, cell culture forms, seeding plates, etc.

Works with supervisor to implement corrective actions if discrepancies are found.

Organizing vendor files

Supports verification and inspections of QA Document Control Room if needed

Ensure adherence to company policies, industry regulations, and quality standards in all document management activities.

Maintains the security and integrity of all files and ensures that no document is lost or accidentally discarded/destroyed.

Follows safety policies and procedures. Takes responsibility for safety in immediate work area. Notifies manager of all observed hazardous conditions or unsafe work practices.

High school diploma or equivalent; an associate degree or relevant certification is a plus.

Proficiency in document management and record keeping.

Proficient with the Microsoft suite (i.e., Word, Excel, PowerPoint, etc.) and Adobe.

Strong organizational skills and attention to detail

Ability to work with electronic documents management systems.

Effective communication and teamwork skills.

Works effectively within teams with rapidly changing priorities.

Prior experience in a similar role is preferred but not mandatory.

About Us

Adverum 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