Quality Systems Coordinator, Document Control (Contract)

Employer
GRAIL, Inc.
Location
Working from home
Posted
Jun 14, 2021
Ref
1700790793
Required Education
Bachelors Degree
Position Type
Contract
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 www.grail.com.

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 supporting documents.
• Track Document Change Requests and Document Change Controls to ensure reviews and approval are completed within strict timelines.
• Coordinate the review, approval, and archival of GRAIL's controlled documents in accordance with internal policies and regulations.
• Edit and proofread controlled documents for formatting, legibility, completeness, and adherence to Quality templates and procedures.
• 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 internal customers.
• Support initiatives to deliver simplification and integration of quality system requirements and business processes within document management structure to facilitate global business growth.
• 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 standard methodologies.
• 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 performance reviews.

Your qualifications will include:

• Bachelor's degree and experience developing, implementing and leading training activities or equivalent knowledge or experience.
• 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 is required.
• Experience using an electronic document management system required, Veeva Vault, Master-Control, AODOCS highly preferred.
• 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 environment.
• 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 environment.
• Ability to adapt to changes in the work environment; Manages competing demands; Changes approach or method to best fit the situation.
• Ability to deal with frequent change, delays, or unexpected events.
• 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 .