Senior QTC Engineer

About Us:

Endpoint is an interactive response technology (IRT®) systems and solutions provider that supports the life sciences industry. Since 2009, we have been working with a single vision in mind, to help sponsors and pharmaceutical companies achieve clinical trial success. Our solutions, realized through the proprietary PULSE® platform, have proven to maximize the supply chain, minimize operational costs, and ensure timely and accurate patient dosing. Endpoint is headquartered in Wakefield, Massachusetts with offices across the United States, Europe, and Asia. Endpoint is a subsidiary of Fortrea Holdings, Inc.

Position Overview:

The Senior QTC Engineer is responsible for managing and supporting assigned QTC activities, including coordinating client and regulatory inspection preparation and support activities, preparing training materials for internal personnel, and performing regulatory intelligence activities. They will also be responsible for designing, evaluating and implementing process improvement initiatives, maintaining the endpoint Quality Management System (QMS) to ensure compliance as set forth by regulatory agencies, and providing direct and consultative efforts regarding computerized systems validation of software, services, and supporting tools.

• Host, support, and participate in client external audits, including coordination and preparation of audit responses, and follow-up activities.
• Design, implement, and evaluate process improvement efforts cross-functionally across endpoint departments, collaborating closely with operational delivery stakeholders.
• Performs and participates in audits and management of critical service providers and vendors by verifying that the vendor meets minimum regulatory, privacy and security requirements, including ensuring timely follow through on observations.
• Advise, collaborate, and/or manage efforts relating to internal and external tool validation in line with documented assessments of risk and defined scope of usage.
• Provide consultative support in matters of Quality Management System development and Computerized Systems Validation (CSV).
• Support the CAPA program including facilitating the completion of outstanding CAPA actions with the appropriate stakeholders, participating in and orchestrating Root Cause Analysis meetings with the applicable endpoint staff, defining and implementing Corrective Actions and Preventive Actions, and evaluating the effectiveness of past CAPAs.
• Perform development and revision of Controlled documents such as Policies,  Standard Operating Procedures, Templates and Work Instructions, including ensuring that procedures meet minimum regulatory, privacy and security requirements.
• Support all aspects of the Internal Audit program, including preparation of the audit plan, execution of the audit, and creation of Internal Audit reports upon assignment.
• Work closely with internal departments, including Operations, Product Development, and Information Technology to assure compliance with internal quality systems and regulations issued by the Food and Drug Administration (FDA) and other applicable regulatory bodies and with applicable privacy and security requirements  
• Participate in conducting periodic Product Quality and Management Review, including tracking, trending all KPIs (QTC metrics) and design action plans to address trends.
• Represent QTC on multi-disciplinary project teams as required

• M.S. degree and minimum 4 years of related experience OR BS/BA degree and minimum 6 years of related experience

• Familiarity with the appropriate regulations, including 21 CFR Part 11, Good Clinical Practices (GCPs), Annex 11, applicable ICH guidelines (ICH E6)
• Relevant experience preferably in the clinical trial industry, IRT experience is highly desired.
• Certification in Quality Assurance or Regulatory Affairs preferred
• Experience in developing SOPs for quality assurance and compliance.

• Strong communication (written and verbal), organizational, and interpersonal skills.
• Demonstrated ability to work in a fast-paced, cross-functional team environment.
• Highly diplomatic and tactful individual with exceptional critical reasoning skills who is detail oriented.
• Proactive team player enthusiastic with high work ethics.·        
• Experience with Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point).
• Project management skills and high level of attention to detail.

Endpoint Clinical does not accept unsolicited resumes from search firms or any other third parties. Any unsolicited resume sent to Endpoint Clinical will be considered Endpoint Clinical property, and Endpoint Clinical will not pay a fee should it hire the subject of any unsolicited resume.

Endpoint Clinical 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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