Susan Girardin
Worcester,MA
Summary
Accomplished Documentation Professional offering 23 years of experience in Biotech setting. Successful leading high-performing teams and partners to sustain product vision, roadmap and business goals. Exceptional technical expertise to effectively understand and translate technical information for both technical and nontechnical audiences. Offering expertise in creating, organizing and managing documentation for cGMP requirements. Expert VEEVA Vault and GEODE database user bringing strong technical acumen, excellent communication skills and unsurpassed dedication to quality and accuracy.
Overview
25
25
years of professional experience
1
1
Certification
Work History
Lead Documentation Specialist
SANOFI GENZYME
01.2009 - Current
- Review/process over 50 documents (monthly) to ensure accurate concise documentation is submitted to meet cGMPs and internal document requirements.
- Monitors quality and quantity of documentation output.
- Provides guidance to Documentation Specialists to ensure compliance with cGMPs and SOPs and provides coaching.
- Monitor and close TCRs and ensure closed files are uploaded into electronic locations.
- Monitor and close over 30 Science Approved Drafts a month.
- Archive/document numerous over 30 Science Approved Drafts a month.
- Key Contributions: Created Document Change Requests (DCR) and Work Instruction (WI) for GEODE DCR Converted new QDMS DCR to PDF form for future use with electronic documentation system.
- Work with IT department to convert existing database from FileMaker to SQL (functionality, design) (project halted)
- Streamlined Periodic Review program so notifications and logs are processed electronically (varies between 30-60 a month).
- Prepared new database manual.
- Point person for several Science organization documentation projects (Blaze LIMS, BD CAPA project, GTO San Diego shutdown and build out project)
- Monitor and close expired Science Approved Drafts and Temporary Change Requests Implement various Job Aids for Technical Services Documentation that work in conjunction with related Standard Operating Procedures
- Point person for various Documentation projects within Analytical Development department.
Senior Documentation Specialist RDQA Technical Services –Documentation
SANOFI GENZYME
01.2007 - 01.2009
- Responsible for working with primary originators of documentation to translate documentation into written form as required by Good Laboratory Practices (i.e., 21 CFR Part 58) and/or current Good Manufacturing Practices (21 CFR, Part 210 and 211) regulations.
- Ensure that documentation is written, edited, reviewed, and approved to meet established guidelines.
- Issues document change requests and documentation status reports, batch records, stability protocols and associated historical data, writes departmental SOPs.
- Provides guidance to other employees, as needed Performs data entry for tracking documents, Science Approved Drafts (SADs), Standard Operating Procedure (SOP) number issuance, adding new SOP category codes, etc.
- Key Contributions: Created Job aids for various Documentation processes, editing new, existing SOPs, processing Document Change Request (DCR), Temporary Change Requests, batch records.
Senior Documentation Specialist
SANOFI GENZYME
01.2003 - 01.2007
- Responsible for editing and distributing Standard Operating Procedures (SOPs) within Quality Systems Documentation department.
- Oversee pre-audit preparations and act as FDA point person; ensure timely responses to audit requests as observer on internal audits conducted by Quality Assurance
- Interact with professionals throughout Sanofi Genzyme, providing technical/monthly reports, fielding general inquiries and imparting advice on document review submission guidelines.
- Retrieve archived history files and technical reports.
- Institute and provide informal instruction on aids for day-to-day job functions.
- Provide statistical reporting for Document Change Request (DCR) Log. Book entries.
- Key Contributions: Received award for contribution to Sanofi Genzyme's Support Services and Thyrogen Scale Up projects that included editing and distributing SOPs, attending project meetings to stay on top of changing deadlines and provide document status updates.
- Designed binder of signatories and organizational charts compiled by department to expedite SOP review and sign-off process; introduced schedule that guided document specialists in taking documents to scheduled locations for review and sign-off.
- Created job aids for posting documents into Livelink database; that earned commendation for their clear explanation of database/documentation update processes and procedures.
- Compiled and presented detailed PowerPoint presentation; project thoroughness helped convince environmental group to add documents into our Documentation system.
- Conducted Approved Draft training seminars for Documentation Training Initiative.
- Completed Fundamentals of US Regulatory Affairs course in conjunction with Regulatory Affairs Professional Society.
Documentation Specialist II
SANOFI GENZYME
01.2001 - 01.2003
- Promoted to position to ensure accurate drafting, editing, review, and approval of Standard Operating Procedures within established deadlines.
- Processed and distributed between 20-30 SOPs a day to lab technicians. manufacturing/warehouse staff, and other professionals to facilitate timely product shipment and delivery to customers.
- Provided customer support on requests for technical reports, approved drafts, document status, and archived material.
- Key Contributions: Served as facilitator, and received special award for, contributions to Sanofi Genzyme's high-profile D-Skid Bioreactor and Myozyme projects supporting introduction of Myozyme product line to treat Pompe's Disease.
- Assisted in writing and updating departmental Standard Operating Procedures.
- Proofread industry publication, Good Practices and Compliance for Electronic Records and Signatures
- Completed Project Fundamentals seminar covering project management skills; enrolled in company-sponsored Effective Business Writing workshop.
Documentation Specialist 1
SANOFI GENZYME
01.1999 - 01.2001
- Provide administrative support.
- Key Contributions: Developed considerable knowledge of Genzyme, its products and services, and industrial sector.
- Originally recruited as Quality Systems Documentation temporary staff contracted through Ranstad (1998-1999); brought on as full-time employee based on exemplary performance.
- Tracked versions of Standard Operating Procedures and participated in reconciliation project for outstanding SOPs.
Education
Associate of Arts Degree - Administrative Assistant
Newbury Junior College
Holliston, MASkills
- Tracking Document Flow
- Electronic Document Preparation
- Customer Service
- Data Accuracy
- Documentation Management
- Documentation Submission readiness
- Editing and proofreading
- Strong Attention to Detail
- Workflow Management
- Interpersonal Skills
- Organizational Skills
- User Support
- Decision-Making
- Time Management
- Adaptability
Certification
Certificate in Technical Communications (in progress) - UCLA Extension Online
Professional Development
- Internal Auditor Seminar (2004)
- Project Management Fundamentals
- Fundamentals of US Regulatory Affairs
- Dealing with Conflict
- Listening Skills
- Technical Writing and Editing
- SOP Writing Workshop
Awards
Various spot awards for outstanding commitment to customer service for daily job responsibilities and projects.
Timeline
Lead Documentation Specialist
SANOFI GENZYME
01.2009 - Current
Senior Documentation Specialist RDQA Technical Services –Documentation
SANOFI GENZYME
01.2007 - 01.2009
Senior Documentation Specialist
SANOFI GENZYME
01.2003 - 01.2007
Documentation Specialist II
SANOFI GENZYME
01.2001 - 01.2003
Documentation Specialist 1
SANOFI GENZYME
01.1999 - 01.2001
Associate of Arts Degree - Administrative Assistant
Newbury Junior College
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