Sr. Analyst, Quality Trust & Compliance presso Endpoint Clinical

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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
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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.


Accountabilities:
• · Demonstrate efficient and accurate completion of all responsibilities.


• Experience:
• 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
• 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 required

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• 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.