QC Technical Compliance Specialist

**Core Hours: Monday \- Friday, 8am\-5pm** **Remote/Hybrid Position \- Must be located in Colorado for occassional onsite activities** **Purpose and Scope** The Quality Control Technical Compliance Specialist is a technical and compliance role within the QC functional area. The primary functions related to this role include completing change controls, deviations, procedure updates, CAPAs and continuous improvement initiatives. Additionally, this role will facilitate collaboration between the investigations writers (investigators), document writers in other groups and QC leadership to reach proper technical decisions related to the types of records owned within QC. **Essential Duties \& Responsibilities** * Assume an in\-depth compliance role in the QCC laboratory, including writing change controls, owning change actions, change assessments, CAPAs, deviations, routine document changes, and continuous improvement document changes. * Work closely with the leadership team to redline documents and collaborate with the document writers in other departments to update QCC documents minimizing rework and additional rounds through the edit and approval cycle. * Ensure accuracy and completeness of all documents and records, prior to routing through Veeva. * Collaborate with the leadership team to ensure previous commitments and CAPAs remain in compliance with the revised requirements. * Own and complete change controls related to method updates, specification updates, instrumentation upgrades or retirements, and changes to validated processes. * Ensure all records and documents move through the process adhering to established procedure timelines, following up regularly with stakeholders and facilitating removal of any roadblocks which would prevent on\-time completion. * Serve as a point of contact for QCC and external departments related to external change assessments and change actions. * Serve as a technical Subject Matter Expert (SME) for report reviews and approvals. * Work closely with the investigation writers and management for CAPA discussions, while setting appropriate timelines for implementation and ensuring all dates are met. * Work with leadership to complete CAPA implementation actions and effectiveness checks. * Perform the quarterly trend deviation reports. * Escalate any issues that threaten deadlines to leadership. * Assist departmental leadership in new endeavors including efficiency efforts, organizational tasks, and non\-routine activities that require a higher level of scientific skills. * Attend T3 Academy and drive completion of process improvement projects for the department. * Upon delegation, assume a supporting role to the management team for activities such as the issuance of COAs, test methods and specifications, and participate in project meetings. * Maintain a positive atmosphere of teamwork, camaraderie, and respect towards co\-workers. * Perform various other duties as assigned. **Knowledge, Skills \& Abilitie