Sr. Analyst, Quality Trust & Compliance (Systems Validation & Compliance)

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.

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

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.