Sr. Analyst, Quality Trust & Compliance bei Endpoint Clinical
Endpoint Clinical · Vereinigte Staaten Von Amerika · Remote
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.
- 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
- - 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.
- · 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
Responsibilities:
Responsible to perform the following QTC product release duties
Accountabilities:
Skills required
- 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.
