About the Job

The Senior QA Specialist, Document Control works as part of a new product team, focused on improving blood-based cancer diagnostic capabilities in areas such as cancer detection, minimum residual disease, and other related applications. This team is comprised of talent from across the Roche ecosystem, including Roche Diagnostics, Roche Pharma and Foundation Medicine, operating as a single unit. 

The Senior QA Specialist, Document Control leverages their experience to lead programs, mentor their peers, develop and implement regulation-adherent processes, lead assessments and process improvements to further improve quality functions, formalized procedures, operations and systems. The Senior Specialist is responsible in order of business priority for inspections, monitoring, auditing, revising quality standards per regulation and business procedural changes, and recommendations to improve the quality of processes and products. 

Key Responsibilities

• Act as the administrative leader for electronic Document Management System (eDMS) Veeva Vault. 
• Coordinate all aspects of the full operation, implementation, and maintenance of the eDMS for controlled issue, retrieval, archiving of regulated documents to support site operations. 
• Support and take ownership in the new product development document creation project, supporting new documents as needed in set-up, formatting, editing/processing, and collaborating with the team. 
• Ensure quality and detail in creation/management of documents, and in the technical word-processing/editing of SOPs and other documents. 
• Responsible for maintaining, updating, and versioning of all policies and procedures and forms. 
• Perform document quality checks on all controlled documents in the eDMS. 
• Coordinate the management of periodic review for required documents within the eDMS. 
• Assist document owners in creating documents and workflows in eDMS. 
• Create new user accounts in eDMS system (Veeva), and grant access to users for DocuSign access. 
• Support implementation of corporate Records Schedule and Retention Program. 
• Serve as primary contact for all archiving of validation documentation and scan all documents in need of upload to the server. 
• Maintain and oversee Quality controlled records storage QA Document Control Room. 
• Lead Biopharma and/or FDA and other regulatory agency inspections for the backroom support/document retrieval. 
• Participate and prepare for Biopharma and/or other audits/inspections. Complete pre-audit requests for documentation and participate as a team member in the Audit Back Room. 
• Co-share responsibilities in the Audit Front Room on an as needed basis. 
• Work closely with the Quality Design Assurance department to continue the Design History File migration of documents to Veeva.
• Issue Laboratory Notebooks and document IDs on an as needed basis. 
• Manage the process for offsite storage of documents to Iron Mountain. 
• Work with management in compiling required metrics and data for Quality Management Review to meet regulatory requirements.
• Monitor and respond to requests made within the QDocs Hypercare Slack channel. 
• Maintain the disaster recovery binders with latest documentation in the QA SharePoint. 
• Provide support to the Training Manager with the training matrix, and any training related tasks in the Cornerstone system. Additional support to other QA activities as needed. 
• Comply with the hybrid-role of 3 days per week minimum required onsite, 2 days remote. 
• Maintain availability to work outside of regularly scheduled shift as needed to support the labs. 
• Maintain attention to detail in a fast-paced workflow environment. 
• Other duties as assigned. 

Qualifications

Basic Qualifications

• Bachelor’s degree or related field with 5+ years experience in the medical device, diagnostics, clinical laboratory or biopharmaceutical industry – preferably in a QA environment, OR
• Associate’s degree in science or related field with 7+ years experience in the medical device, diagnostics, clinical laboratory or biopharmaceutical industry – preferably in a QA environment, OR
• High School Diploma or General Education Degree with 9+ years of strong experience in the medical device, diagnostics, clinical laboratory or biopharmaceutical industry – preferably in a QA environment 

Preferred Qualifications

• Experience working with electronic document management and quality management systems highly preferred. Experience with Veeva Vault is a plus
• Previous Document Control or Record Management experience required
• Exposure to regulatory compliance knowledge including GMP, ISO 13485, ISO 15189, CAP/CLIA, NYS, states, GCP, IVDR, and 21 CFR Part 11 Compliance
• Demonstrated ability to lead teams and mentor staff
• Ability to multitask within specified timelines
• Ability to work well under pressure while maintaining a professional demeanor
• Detailed oriented with excellent prioritization and organizational skills
• Strong interpersonal skills that include excellent skills in written and oral communication, collaboration, and problem solving with departments and colleagues
• Understanding of HIPAA and importance of privacy of patient data
• Commitment to FMI values: patients, innovation, collaboration, and passion.

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