About us:

endpoint is at the forefront of the evolving e-clinical technology industry with more than 20 years of experience designing, enhancing and deploying robust, configurable IRT solutions.

At our core is a commitment to the continuous evolution and enhancement of IRT to improve your trial management. Our unique, single-focus approach makes endpoint the only company with the knowledge and experience needed to drive IRT and e-clinical integration paradigm shifts in the industry.

Position Overview: The Vendor Management, Document Management and Training Quality Engineer is primarily responsible for administration of the vendor management, document management and training systems as set forth by regulatory agencies and endpoint's Compliance Management System (CMS) as well as providing oversight and assistance for QTC activities.

*This role can be remote, but must keep working hours between 9 - 6 PM PST.

Responsibilities:

Vendor Management:

• Administer the endpoint vendor qualification process, including data base administration, vendor audits and acceptance activities of implementing third party software solutions
• Lead and execute initiatives around vendor data gathering and analysis, vendor management best practice research, process mapping, and recommending alternatives for improvement.
• Ensure required aspects of the endpoint Vendor Management System are trended on a routine basis for presentation to QTC Management for review

Document Control:

• Administer the document control system, including the development and revision of controlled documents such as Standard Operating Procedures (SOPs), Policies, Validation Documentation and Work Instructions.
• Perform CMS documentation reviews on controlled documents such as SOPs, Work Instructions and Policies as well as provide feedback to key stakeholders as needed.
• Represent QTC on the Change Control Board (CCB) for documentation changes.
• Facilitate the document information asset life cycle, including onboarding, maintenance, and archival of information assets in the endpoint Compliance Management System.
• Ensure required aspects of the endpoint Document Control System are trended on a routine basis for presentation to QTC Management for review

Training:

• Administrate and prepare training materials for all endpoint departments and serve as quality and regulatory compliance subject matter expert for training execution.
• Work closely with internal departments, including Operations, R&D, Information Technology to assure training compliance with internal quality systems and regulations issued by the Food and Drug Administration (FDA), and other applicable regulatory bodies.
• Assist in preparing and reviewing training materials for different regulations and quality systems and deliver training to endpoint personnel.
• Ensure required aspects of the endpoint Training Management System are trended on a routine basis for presentation to QTC Management for review

General:

• Participate in cross functional initiatives with Operations, R&D, IT and other teams to improve adherence to regulations and internal procedures.
• Participate in Process Improvement processes.
• Other duties as assigned

Qualifications:

Education:

• Bachelor’s degree in related scientific or equivalent professional experience

Experience:

• 3 year of relevant working experience within a regulated environment preferred
• Familiarity with FDA regulations (21 CFR Part 11, EU Annex 11) regulations and GxP
• Knowledge of U.S. and international regulatory standards and guidelines
• Experience with a QMS a plus, but not required

endpoint is an equal opportunities employer AA/M/F/Veteran/Disability.

Pursuant to the San Francisco Fair Chance Ordinance, we will consider for employment qualified applicants with arrest and conviction records.

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