QA Specialist I Document Control (Contract)

Adverum Biotechnologies, Inc. • Redwood City, CA

4d • $25 - $30 • Onsite

About The Position

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/temporary role is designated to be onsite (HQ -Redwood City); duration will be up to 6 months.

Requirements

• 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.

Nice To Haves

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

Responsibilities

• 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.

Benefits

• medical
• dental
• vision
• 401k
• STD/LTD
• life and accident insurance
• paid time off or flexible paid time off
• annual bonus
• Company equity incentive award plan

What This Job Offers

• Job Type: Full-time
• Career Level: Entry Level
• Education Level: High school or GED