Quality Systems Coordinator, Document Control (Contract)
Posted on: June 12, 2021
GRAIL is a healthcare company whose mission is to detect cancer
early, when it can be cured. GRAIL is focused on alleviating the
global burden of cancer by developing pioneering technology to
detect and identify multiple deadly cancer types early. The company
is using the power of next-generation sequencing, population-scale
clinical studies, and state-of-the-art computer science and data
science to enhance the scientific understanding of cancer biology,
and to develop its multi-cancer early detection blood test. GRAIL
is headquartered in Menlo Park, CA with locations in Washington,
D.C., North Carolina, and the United Kingdom. It is supported by
leading global investors and pharmaceutical, technology, and
healthcare companies. For more information, please visit
The individual will be responsible for maintaining elements of
the GRAIL Quality Systems with an emphasis on the Document Control
Program. You will work cross-functionally to ensure alignment
implementation of a Document Control Management program while
adhering to strict timelines, maintaining version controls, and
managing reviewers and approvers. This role will be a hands-on
resource reporting to the Director, Quality Systems and will also
require routine coordination of training needs with QA colleagues
and business partners.
You will :
- Responsible for the oversight and continuous improvement of
efficient, effective and compliant processes supporting GRAIL's
Corporate Document Management System.
- Collaborates with key internal partners, as well as operational
leads, to ensure staff receives all relevant Policies, SOPs,
Forms/Templates per job role.
- Maintain controlled documents, including creating draft
documents, maintaining profile card metadata, and linking
- Track Document Change Requests and Document Change Controls to
ensure reviews and approval are completed within strict
- Coordinate the review, approval, and archival of GRAIL's
controlled documents in accordance with internal policies and
- Edit and proofread controlled documents for formatting,
legibility, completeness, and adherence to Quality templates and
- Build and Run reports to ensure accuracy and completeness of
the document control process.
- Participate in validation testing for system implementations
and updates documents (SOPs, reports, protocols, specifications,
etc.,) route for review and approval, issue effective SOPs and
obsolete older SOPs.
- Manage Document Control email inbox with timely responses to
- Support initiatives to deliver simplification and integration
of quality system requirements and business processes within
document management structure to facilitate global business
- Call out areas of non-compliance, risk and/or potential
improvement to Management and develop plans for appropriate action
to address causes of deficiencies.
- Establishes and maintains effective cross-functional team
communications to advance GRAIL's quality activities and promote
- Address, respond to, and complete CAPAs associated with
document management needs and gaps, and provide company training
metrics for management reviews.
- Support inspection readiness plans during inspections on
training related matters.
- Hiring, managing, developing, retaining, coaching and mentoring
staff including setting individual and team goals and conducting
Your qualifications will include:
- Bachelor's degree and experience developing, implementing and
leading training activities or equivalent knowledge or
- Minimum of 5 years of experience performing a quality
management function, preferably with experience in Document and
Records Management and/or training.
- Working knowledge and understanding of regulations and
standards, including but not limited to QSR, ISO Quality System,
CAP/CLIA, NYS, ISO 15189 and other applicable industry requirements
- Experience using an electronic document management system
required, Veeva Vault, Master-Control, AODOCS highly
- Proven track record to efficiently manage workload under tight
deadlines and pressure in a composed manner.
- Demonstrated ability to perform work with a high degree of
accuracy and completeness.
- Requires outstanding interpersonal, verbal and written
communication skills are essential in this collaborative work
- Comfortable in a fast-paced environment with minimal direction
and able to adjust workload based upon changing priorities.
- Demonstrated project management experience developing processes
and leading their implementation in a cross-functional
- Ability to adapt to changes in the work environment; Manages
competing demands; Changes approach or method to best fit the
- Ability to deal with frequent change, delays, or unexpected
- Experience with auditing and experience representing and
responding to regulatory agency audits
- Must be able to work in a biohazard environment and align with
safety policies and standards outlined in the Safety Manual.
We are an equal opportunity employer and value diversity at our
company. We do not discriminate on the basis of race, religion,
color, national origin, gender, sexual orientation, age, marital
status, veteran status, or disability status.
GRAIL, Inc. and its affiliates and subsidiaries ("GRAIL") does
not accept any liability for fees for resumes from recruiters or
employment agencies ("Agency"), without a binding, written
recruitment agreement between GRAIL and Agency describing the
services and specific job openings ("Agreement"). GRAIL may
consider any candidate for whom an Agency has submitted an
unsolicited resume and explicitly reserves the right to hire those
candidate(s) without any financial obligation to the Agency, unless
an Agreement is in place. Any email or verbal contacts with any
person within GRAIL is inadequate to create a binding agreement.
Agencies without an Agreement are requested not to contact any
hiring managers of GRAIL with recruiting inquiries or resumes.
Agencies interested in partnering with GRAIL may contact GRAIL's HR
Department through our Customer Service team.
Keywords: Grail, Eugene , Quality Systems Coordinator, Document Control (Contract), Other , Remote, Oregon
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