Document Control Quality Systems
Resume:
Jenny Craytor
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= Profile Skills / Summary:
Proven the ability to perform and manage day-to-day GxP Document Control workflow and Training operations
(paper base and/or EDMS). with high-quality standards, in a fast-paced and high priority change environment. Supporting and maintaining the QMS, including Document Control, Training, Quality Systems, and other Quality Records. Excellent communication skills with the ability to collaborate with a wide range of stakeholders in various departments.
Great individual with the ability to effectively/efficiently accomplish projects. Step up and takes ownership of a given project and demonstrates with elevated level of dependability and accountability. Experience with Electronic quality systems (Veeva QualityDocs and Veeva QMS) and Learning Management Systems, SharePoint, and DocuSign.
Conversational Languages: Mandarin, Cantonese, Malay, Teochew and Hokien Education, Certifications, Licenses, and Training:
• B.S., -Bus. Administration with the concentration in Econ/Finance Notre Dame de Namur University, Belmont, CA
• Certification in Quality Management Systems (QMS) ISO 13485: Lead Auditor (Certificate Number: LA2011- 6-001)
• Familiar with US 21 CFR Parts 11, 58, 210, 211, 820, Q7, Q9, Q10 and Annex 11
• Familiar with US FDA, EMA and ICH regulations and guidelines Technical Skills:
Expert skills in Veeva Vault Quality Suites (VVQ), Document Lifecycle within Veeva Vault QualityDocs, MasterControl, DocuSign Part 11 module.
Microsoft Suite: (Advanced MS Word, Excel, MS Access, PowerPoint, Visio, etc.). and Adobe Basic working knowledge of CAD (SolidWorks) Software and AutoCAD, QUMAS, ChatGPT, SAP, SharePoint Documentum, Dropbox, Adaptive Compliance Engine (ACE), SABA Cloud Other EDMS: Propel (PLM), Qualio and Montrium, Livelink, Professional Experience:
NUVATION BIO OCT-2024 – DEC-2024
QA Document Control Specialist (FTE) New York, (remote)
• Responsible for a wide variety of activities about Document Control, Records Management, Training program, and improving Nuvation Bio’s Quality System
• Administration and maintained the GxP training program tracking, and timely completion of training assignments for all team members, and overseas staff members in China.
• Prepared and sent completed training forms through DocuSign to capture employees’ signatures.
• Responsible for formatting, proper spelling, and text clarity for any written documents submitted to document control.
• Archived documentation to ensure traceability and accessibility. TAKEDA PHARMACEUTICAL Aug 2023 – Sep 2024
R&D Quality Documentation Specialist}/QMS Document Archivist (Research, CMAS) (Contract – LanceSoft Employment Agency, VA) (remote)
Accountability, Behavioral, Competencies and Skills:
• Function as the subject matter QMS Document archivist specialist on archiving and records management and alignment across R&D (Rare Diseases) department through archiving, retention policy, and controlled (scheduled) disposal of records.
• Representative for Rare Disease Research Group as a Content Manager Archival System (CMAS).
• Provided and possessed the ability to use computer software programs (e.g., email, word processing, spreadsheet, ChatGPT, and project management) to aid the archival process.
• Demonstrated high standard of quality knowledge and experience of technologies, systems, and processes related to quality records management/archiving.
• Primary responsibility completing the Takeda Global form, for Business Record Destruction and Disposal Form, which includes any Legal Hold notice along with the document destruction archive inventory list to the manager for approval per Takeda’s SOP.
• Managed confidential information and issues effectively, with sensitivity, and without breach of confidentiality. Jenny Craytor
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• Coordinated and supported retrieval of archived records to support research needs or regulatory requests for information.
• Possessed the ability to communicate with internal and external stakeholders of the process effectively.
• Coordinated and supported manager/Business Operations and Legal teams on Statements of Work, Master Service Agreements, Confidentiality Agreements, PO, and any Payment due. OLEMA ONCOLOGY
Sr. Document Control Specialist (GXP)/Quality Systems (FTE) Oct 2021 – Mar 2023 EDMS (Veeva Vault Quality Suites):
My position, responsibilities and accomplishments were:
• Oversaw the day-to-day operations of the Document Control and Training systems, Veeva Vault QualityDocs Suites
• Worked collaboratively with cross-functional teams’ stakeholders to ensure compliance with regulatory requirements and internal quality standards.
• A core team member for the implementation of Veeva Vault Quality Suites at Olema.
• Served as an SME Veeva Vault Quality Document Control processor.
• Participated in and supported documentation, testing, and migration for the successful implementation of Veeva Document Control. This included the execution of the Quality Test Plan and Production Vault, Documents Migration. I also QC’ed the document loader and a large list of Documents before “Go Live” on 10/1/2022.
• I successfully used the VV sandbox by completing practice exercises and Quality Test assignments.
• Helped prepare all DocuSign documents for validation.
• Collaborated to train other VV users to perform their tasks.
• Actively participated in the Document Migration project, which included the creation of password protection on all Master Fillable Forms and other kinds of GXP documents.
• Provided and supported Olema’s continuous improvement efforts of the Quality Management System (QMS). Identified any gaps and discrepancies in the controlled documents process system. Training:
• Collaborated with all Functional managers to establish employees training syllabus and requirements.
• Performed administrative activities for QualityDocs and Training as the administrative user role.
• Trained and monitored end-users with any issue(s) that arose during the execution of the VV Document Control process steps. Followed up and assessed with end-users to ensure the training provided had helped them to perform their professional tasks.
• Developed a Training database in Dropbox or SharePoint to capture all on/Off boarding employees and were complied.
• Generated and provided them with the list of Read and Understanding Training syllabus and requirements via Veeva Vault Quality Suites.
• Ensured all GXP employees’ training files were generated, maintained, complied with and were easily accessible to Functional heads.
• Trained new and existing employees on Lifecycle of document processing, if needed.
• Demonstrated proficiency level with Microsoft Office products required to perform the tasks. Document Control:
• Actively participated and supported in Olema Phase 3 SOP development projects.
• Created and maintained document templates, as needed, while ensuring continuous improvement and user friendliness.
• Recommended and provided improvements procedures in current document control systems, provided written SOPs, Forms, and Work Instructions, reviewed, and commented on related documentation procedures, and ensured their proper implementation works well with other cross-functional areas activities.
• Assisted with uploading and certifying documents into Veeva QualityDocs to align legacy processes with current ones.
• Assisted GMP coworkers on generating urgent Test Method and Specification to CMO for use.
• Provided support to the Quality department by assisting in the execution of GXP quality activities, including but not limited to the creation and processing of document change control documentation, management of SOPs, support, and maintenance of employee training operation programs and other GXP record processing and archival.
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• Created Fillable forms and Templates for Controlled documents/Forms.
• Demonstrated the ability to perform complex document control processes. Functioned as the company expert and provided end-user assistance in Change Control, Training process, and all Document Control issues.
• Primary person responsible for ensuring Quality Document Control processing in a timely manager.
• Generated and processed IT Change Control and Risk assessment on Quality Veeva Vault Quality Docs related changes.
• Provided Quality manager monthly quality metrics to document training and document processing in QA.
• Provided continuous Document control and Training program gaps analysis and improvement. BAYER PHARMACEUTICALS, Berkeley, CA July to Aug-2021 Sr. Document Control Specialist (Rose International, Inc. staffing agency) (Note: The CureVac COVID-19 vaccine project was cancelled)
• Reviewed Document Change Control Management (GXP activities) procedures.
• Reviewed Berkeley Documentation Style Guide, Document Numbering system, and Good Documentation Practice.
• Performed Gap Analysis and Risk Assessment for HACCP for Final Product Manufacturing Suite KARTOS/TELIOS Therapeutics Inc., Redwood City CA (Bayside Solutions staffing agency) Sr. Document Control Specialist/Quality Systems Specialist (Contract) December (2020) to March (2021)
• Developed, maintained, and administrated SOPs and other GXP controlled documents and ensure they reflect current practices and regulatory requirements and are consistent across documents.
• Created an envelope in DocuSign and routed the documents to the appropriate approvers for approval.
• Organized and maintained the paper-based and electronic filing system in BOX. TRICIDA, INC., South San Francisco, CA
Quality System Specialist (FTE) July 2020 to December 2020
• My primary responsibility is to support the Quality Systems team on a variety of tasks or projects that span across document control, training, inspection management and other quality event modules (including, but not limited to deviations, CAPAs, and change controls) and Internal and External correspondence.
• Primary responsible for company’s electronic Quality Management System, such as SharePoint, Adaptive Compliance Engine (ACE) and DocuSign.
• Maintained and published ASL
• All GXP Change Control related activities.
o Managed and Continuous Improvement of Tricida Change Control management system.
• Primary responsible for GXP Document control related functions: o Organized, filed, and cataloged legacy-controlled records in Document Control’s cabinets. o Maintained soft and hard copy of Legacy documents. o Performed Document Periodic Review in a timely manner. o Maintained weekly metrics for various documents pending/closure.
• Managed the GXP Training Program.
o Ensure all training is compliant and all curricula are current and accurate. o Assisted with training attendance records and cataloging and filing activities, as well as uploading completed forms into the Learning Management System (LMS). ASTRAZENECA (formerly Acerta Pharma Inc.), South San Francisco, CA Sr. Quality Systems Specialist/Document Control (FTE) Nov 2015 to Apr (2020) Provided widespread support for the overall QA Quality System. Collaborated and/or volunteered with other Functional Area managers on special projects assigned QA, as needed. An appointed SME for GXP documentation related issues.
EDMS (Master Control)
Sr. Quality System Specialist/Document Control
o Collaborated closely with stakeholders to create, format, and manage controlled documents and templates within the electronic Document Management System (eDMS) (MasterControl). o Oversaw the entire document lifecycle, including creation, routing, review, approval, periodic review, and archival to maintain data integrity and compliance. Jenny Craytor
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o Manage paper-based records and ensure proper archiving and retrieval processes are in place. o Performed day-to-day tasks, as well as managed other projects that supported company objectives and company’s goals.
o Participated in the Hiring internal staff process. Strong ability to persuade and influence others to move forward the projects.
o Maintained Controlled Documents and non-controlled documents are fully secure to ensure integrity of the content.
o Provided ongoing as SME for all QA support of all Controlled documents and Training processes in Master Control. Worked with various departments to produce high-quality and accurate documents under a strict timeline, and to ensure consistency between related documents and/or other cross-referencing documents. For example, functional areas were: Medical Writing, Procurement, RA, Clinical Operations and Drug Safety.
o Performed and ran meaningful reports to track and trend the document processes in QA. o Scrutinized all draft GXP controlled documents submitted to QA for approval before routing them for final approval.
o Worked closely with IT team members assisting them with the CSV Documentation (IQ, OQ and PQ). It is very crucial to meet the Validation deadline. Manufacturing systems need to be validated before production.
o Met with Business Owners and/or Systems Owners to discuss the CSV Documentation as needed. Notify and release documents to the appropriate group in a timely manner for use. o Supported the Integration and Migration activities of Acerta documents to AstraZeneca (AZ) documents. o Supported continuous improvement of Quality System processes and procedures. o Supported all CMC and CMO documentation in an orderly manner. o Supported the internal and external RA audit process. Training Specialist
o Supported GxP training initiatives within the organization, acting as a Subject Matter Expert (SME) for training programs. Trained newly recruits on all aspects of the document control system. o Ensure training content is developed, maintained, and assigned appropriately in the eLMS. o Supported internal audits and regulatory inspections by providing training records and documentation as needed.
o Administered the eDMS and electronic database for Learning Management System (eLMS), ensuring system compliance through periodic reviews.
o Ran and provided overdue training report to functional management. o Trended and ran Training report to capture the effectiveness of the training process. o Trained and had the ability to transfer SME and understanding to other employees or Internal Temps. Improved and developed our GXP Training program to ensure compliance with current GXP industries requirements. Provided meaningful training metrics to functional heads monthly. o Collaborated with Functional Area Heads to set up the individual department job codes/curriculums/requirements and for the individual employee’s job roles. o Assisted in the preparation and processing of individual group CVs and Job Descriptions, as needed. o Worked closely with HR group to generate all employees Descriptions and CVs using MasterControl for inspection readiness. Assisted HR with Workday and SABA migration projects during migration process. o Assisted and trained On-boarding for new and existing end-users in EDMS. ZOGENIX, INC-(Biotech/Pharma) Jun to Oct 2015
Sr. Quality Systems Specialist /Document Control (CV Partners R&D Inc.)
• Drove Internal Audit CAPA follow up to ensure -timely Evidence of Completion and CAPA closure. -
• Created- all hard and soft copies Approved Supplier List (US/UK Quality group).
• Primary responsibility for -custody of all employees Training records (hard and soft copy) GENEWEAVE BIOSCIENCES, INC- (Diagnostics Company, a subsidiary of Roche) Feb to May 2015 Sr. QA Document Control/Document Control Manager (CV Partners R&D Inc.)
• Maintained the database for the Product Lifecycle Management (PLM) systems.
• Responsible for supporting the Batch Review and Generating new BOM, SP, RM documents. Jenny Craytor
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• Generated new and revised Part Number, SPECs. and BOM for product release; Assigned and Maintained Part numbers, Components/Raw Materials, Lot numbers and Master Part List
• Created and maintained the DMF and DHR
• Edited and/or updated drawings using SolidWork software.
• Maintained Device Drawings and Drawing Specifications. Using Solidwork software to edit. BAYER HEALTHCARE, Berkeley, CA Jan to Sep -2014
QAD Change Management Specialist/Technical Documentation Specialist (The Fountain Group staffing agency)
• Change Control Management (Manufacturing sites)
o Performed and managed various Change Control duties assigned to Local Change Management (LCM) in the QAD department, which included the Lifecycle of the CCR process according to Bayer’s SOP using the ValGenisis CCR database.
o Collaborated with Analytical, GBD and Clinical group on all Change Control related issues. o Ensured all stakeholders’ comments -were addressed in the Final Implementation Plan -and written clearly to avoid miscommunications between CCR initiator and approvers. o Followed up with responsible group(s) and checked the Effectiveness of the change. o Confirmed that prospective changes do not conflict with other change control or other in-house procedure. o Tracked monthly Quality CCR KPI and KPI process report per functional groups for management review. o Served as a liaison between CMF staff, Global Biological Development process teams, Engineering, QAD, and other teams related to Clinical Manufacturing Organization. LIST OF OTHER COMPANIES I WORKED FOR:
• CARBYLAN BIOSURGERY, INC-, Palo Alto, CA
• MEDIVATION, INC. San Francisco, CA-
• FLEXTRONIC ELECTRONICS TECHNOLOGY, Suzhou (Suzhou Industrial Park), Jiangsu Province, China (Medical Device)
• CRESCENDO BIOSCIENCES, INC (Diagnostic) –
• ABBOTT VASCULAR (Santa Clara and RWC, CA.)
• INTERMUNE, INC., Brisbane, CA (Bio/Pharma Company, a subsidiary of Roche)
• Gilead Sciences (formerly CV Therapeutics ) Palo Alto, CA
• STEMCELLS, INC., Palo Alto, CA-
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