Steven Viernes
San Diego,CA
Summary
Dynamic Quality Professional offering over 15 years of experience in the biotech industry. Proven track record in document control, systems administration/implementation, and training. Proficient in GXP system compliance, Computer System Validation, and FDA regulations/21 CFR part 11 revision. Expertise includes EDMS/Training (Veeva Vault, ComplianceWire) and preparation for internal/external audits.
Overview
19
19
years of professional experience
Work History
Specialist, QA Record Management
Mirati Therapeutics (a Bristol Myers Squib company)
San Diego, CA
02.2022 - Current
- Maintain and support system and processes to protect and secure critical records and information
- Ensure all GxP records are filed appropriately in a timely manner (i.e., hard copy and electronic)
- Maintain electronic GxP records in Veeva Electronic Document Management System (EDMS), including uploading and ensuring accurate classification and metadata entry
- Recognize and resolve documentation and record discrepancies to ensure consistency
- Ensure that processes and policies comply with regulatory requirements for record retention
- Responsible for off-site archival of records and ensuring accurate record retention
- Maintain files for current effective controlled documents as required
- Implemented process improvements, such as the Mirati GxP Glossary and the Business Continuity Document Library, to increase efficiency and reduce costs.
- Partner with various internal departments to coordinate Mirati GxP Glossary accuracy and relevance.
- Maintain standardized templates for essential documents.
- Authoring, review, and revision of controlled documents, including SOPs, forms, policies, and work instructions.
- Support regulatory and internal audits as an SME for record management.
- Support Computer System Validation (CSV) activities, including PQ script authoring & execution.
- Generate metrics to track compliance of controlled documents and periodic review activities.
- Provide technical support for users experiencing difficulties with software applications
Document Control Associate III
Fate Therapeutics, Inc.
San Diego, CA
02.2020 - 02.2022
- Maintain Quality records, including maintaining document archives and off-siting of documents
- Maintain/administer the Electronic Document Management System (EDMS) - Processed 450+ document change orders since November 2020
- Received a 2020 Spot Award for 'exceptional dedication and extraordinary efforts in re-vamping and validation of the Veeva QualityDocs workflows and permissions.' Instructor for classroom trainings/refresher courses for Veeva Super Users
- Lead presenter for Quality new-hire orientation sessions, with over 180 new hires onboarded since November 2020
- Support internal audits related to document control
- Revise, and implement departmental policies and procedures
- Develop, revise, and implement work instructions for document control, Veeva workflow, and label printing procedures
- Batch record, logbook and label issuance.
Quality Assurance Document Specialist I
Halozyme, Inc.
San Diego, CA
07.2018 - 01.2020
- Maintain Quality records
- Maintain/administer the Electronic Document Management System (EDMS) - Processed 200+ document change orders in 2019
- Played key role in implementation of a new Learning Management System (LMS), ComplianceWire, with SSO, EDMS, and HRIS integration; Business Administrator for GxP-related training for 300+ personnel
- Received the 2019 Halozyme Beacon Award, for exceptional cross-functional achievement and living the company's core values in connection with the implementation of ComplianceWire
- Lead instructor for classroom trainings/refresher courses in navigating Veeva Multi-Docs Change Control workflows, with over 50 trainees completing the course since July 2018
- Lead presenter for Quality new-hire orientation sessions, with over 70 new hires onboarded in 2019
- Support internal audits, partner audits, and mock inspections related to document control and training programs
- Played key role in 2019 Swiss Medic Health authority inspection, with over 50 document change orders processed
- Halozyme received manufacturing licensure with no major findings
- Administered Laboratory Notebook program, facilitating issuance, check in/out, and archiving of over 200 notebooks since July 2018
- Develop, revise, and implement departmental policies and procedures.
Software Validation Analyst
Gen-Probe Incorporated
San Diego, CA
01.2006 - 03.2008
- Implemented and led team in validation of a new $2M Clinical Data/Trial Management System
- Coordinated and led cross-functional teams in validation of new software systems
- Ensured 21 CFR Part 11 (Electronic Records/Signatures) compliance for GxP software systems
- Worked with vendors and business users in software/hardware issue resolution
- Liaison to project management, internal clients, Information Systems, and Quality Systems Departments
- Worked with business users to define software user requirements and processes, ensuring business and department needs are met
- Contributed articles for quarterly Information Systems Dept
- Newsletter.
Education
Biological Science
San Diego Mesa College
01.2010
Skills
- GXP system compliance
- Document Management
- MS Office (Word, Excel, PowerPoint, Visio)
- EDMS/Training: Veeva Vault, ComplianceWire
- Revision, implementation of SOPs
- Computer System Validation
- Proficient in FDA regulations/21 CFR part 11
- Preparation for Internal/External Audits
Languages
Spanish
Professional
Timeline
Specialist, QA Record Management
Mirati Therapeutics (a Bristol Myers Squib company)
02.2022 - Current
Document Control Associate III
Fate Therapeutics, Inc.
02.2020 - 02.2022
Quality Assurance Document Specialist I
Halozyme, Inc.
07.2018 - 01.2020
Software Validation Analyst
Gen-Probe Incorporated
01.2006 - 03.2008
Biological Science
San Diego Mesa College
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