Quality systems Specialist/Sr. Specialist Gritstone Oncology
Pleasanton, CA

Job Description

Gritstone Oncology is a fast-growing, innovative biotechnology company developing the next generation of personalized cancer immunotherapies. With distinguished scientific founders, an experienced and diverse management team, a seasoned and successful board of directors, and deep financial backing our goal is to develop breakthrough immunotherapy treatments for patients with cancer by identifying and deploying neoantigens from each patient's tumor to develop personalized cancer vaccines.

The Quality Systems Specialist works in close collaboration across multiple departments to facilitate the quality systems at Gritstone Oncology, including the document management system, training management system, deviation, CAPA, change control and nonconformance workflows. This position supports the GMP drug product manufacturing process with the following responsibilities:

* Function as document control and/or training coordinator, routing tasks to appropriate personnel and keeping workflows running efficiently.
* Support/maintain systems for electronic Batch Records (eBR) and Electronic Quality Management Systems (eQMS).
* Facilitate the process of creating, reviewing, approving and archiving standard operating procedures (SOPs), Batch Records, Work Instructions, and other standard documentation.
* Ensure current versions of controlled GMP documents are readily available to site personnel.
* Maintain the document control system in compliance with all applicable regulations.
* Facilitate the system for archiving of product-specific CMO and internal manufacturing documentation.
* Coordinate the training program to ensure all employees have the correct training tasks assigned.
* Maintain monthly QA metrics reports.
* Support other quality system components as necessary (including documentation related to deviations, CAPA, and change control).
* Establish and maintain a work environment that fosters learning, respect, open communication, collaboration, integration and teamwork.
* Function as a Trainer on eQMS and eBR. Trouble-shoot and answer user questions as needed.

Minimum Education/Experience:

* Bachelor's degree (or equivalent), preferably in scientific discipline or a health-related field.
* Specialist: At least two years of experience in Quality Assurance in a regulated industry.
* Sr. Specialist: At least four years of experience in Quality Assurance in a regulated industry.
* Prefer candidates with working experience in eQMS software systems (Trackwise, Veeva, MasterControl or similar)

Other Qualifications

* Able to work in a fast-paced, start-up company environment.
* Self-motivated, self-discipled and able to function independently and as part of a team.
* Strong organizational skills and attention to detail
* Strategic agility, strong critical and logical thinking with ability to analyze problems
* Strong ability to prioritize, multi-task
* Excellent presentation and written/verbal communication skills.
* Excellent computer proficiency (MS Word, Excel, PowerPoint and Quality Assurance software)