United States onlyAbout 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 Raleigh-Durham, North Carolina with offices across the United States, Europe, and Asia.
Position Overview:
The role of QTC Analyst, Senior is primarily responsible for direct action and oversight of the day-to-day operations of ensuring compliance for product release launch activities and post-launch compliance and ensuring compliance as set forth by regulatory agencies and endpoint Quality Management System (QMS) as well as participate and lead continued growth/improvement projects.
Responsibilities:
- A primary point of contact for resourcing and guidance of product release team
- Provide QTC review and approval of in-process tasks related to product and/or service provision
- Develop and oversee onboarding and training of Analysts on QTC product release team
- Act as subject matter expert and point of contact for Software Development Life Cycle process
- Develop, write, and revise controlled Validation Deliverables and in continuous improvement efforts and procedures and practices related to product release
- Provide ad hoc training to Operations staff on compliance procedures associated with product release
- Responsible to perform the following QTC product release duties
- - Provide QTC review and approval of in-process tasks related to product and/or service provision
- - Generate, perform review, and maintain records of Validation Deliverables documentation and ensure compliance to procedures and processes.
- - Maintain validation documentation in QMS according with company procedures
- Provide support to operations staff to develop, write, and revise controlled Validation Deliverables.
- Act as primary QTC representative and resource to Operations staff with regards to product release
- Maintain validation documentation in QMS according with company procedures
- Assist in preparation, review, and maintenance of reports for identified product events
- Participate in Root Cause Analysis meetings with the Operational staff and provide input on the identification and documentation of Corrective Actions/ Preventive Actions for events of discrepancy or failure of released product
- Assist CAPA team in completion of outstanding CAPA items with the appropriate stakeholders as it relates to product release.
- Support the Governance unit in preparation for External Audits related to product release.
- Perform QMS documentation Quality Control (QC) reviews on controlled documents such as SOPs, Work Instructions and Policies as well as provide feedback to key stakeholders as needed
Education:
- M.S. degree and minimum 2 years of related experience OR BS/BA degree and minimum 4 years of related experience
- Certification in Quality Assurance or Regulatory Affairs preferred
Experience:
- Minimum 2-4 years of relevant working experience within a regulated environment
- Substantial working knowledge of FDA regulations (21 CFR Part 11, EU Annex 11) regulations and current industry best practices
- Knowledge of U.S. and international regulatory standards and guidelines
- Relevant experience preferably in the clinical trial industry, IRT, or CRO experience is highly desired.
- Experience with a QMS and LMS preferred
Skills:
- Strong communication (written and verbal), organizational, and interpersonal skills.
- Strong decision-making skills
- Project management skills and high level of attention to detail.
- Demonstrated ability to work in a fast-paced, cross-functional team environment.
- Position requires a highly diplomatic and tactful individual with exceptional critical reasoning skills
- Experience in developing SOPs in for quality assurance and compliance.
- Strong collaboration and development skills.
- Proactive team player enthusiastic with high work ethics
- Proficient in Microsoft Office applications (Outlook, Word, Excel, Visio, Microsoft Project, Power Point) and Adobe Acrobat Professional.
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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