Pre-Clinical/Clinical QA Manager/Lead with **+ years of experience with Document Control/eDMS/System Specialist/SME/Change Control/Technical Writing/Training Coordinator/Auditing expertise. First-hand involvement in GxP, pharmaceutical, biopharmaceutical, medical device, sterile compounding, and biotechnology industries. Specializing in collaborative working practices, cross-functional collaboration with ability to drive projects to completion. Known for innovative thinking outside the box.

SKILLS

Document Control

Change Control

Technical Writing

CAPA/Deviations/Invest

Auditing

eDMS SME

ECO

GxP requirements

Label Design & Control

Batch Records

Product Release

Site Trainer

Pre-Clinical/Clinical

System Specialist

Critical Thinking

Leadership

Troubleshooting (IT)

Regulations

Data Integrity

Annual Product Review

Vendor Management

Equipment Validation

Quality Agreements

Drive to Completion

Meets Deadlines

21 CFR Part 820, ISO 13485

Collaborative

Attention to Detail

EDMS SYSTEM EXPERTISE

(IMPLEMENTATION AND MANAGEMENT OF EDMS SYSTEMS)

Veeva Vault

FirstDoc

DocCompliance

TrackWise,

ComplianceWire

Box

Master Control

Innovia (Magic)

Oracle Agile PLM

Q-Pulse

Database Development

Smartsheets

*SharePoint

*Cornerstone on Demand

*ETQ Reliance

PROFESSIONAL CONSULTING WORK EXPERIENCE

Enliven Therapeutics: Biopharmaceutical company focused on the discovery and development of small molecule kinase inhibitors to help patients with cancer.

QA Document Control Specialist

Review and approval of documents in SharePoint.

Revision of existing documents.

Assist with the implementation of eDMS and eQMS systems.

Assist with training records and employee training monitoring

May 2023 – May 2023

Alkermes, Inc.:

Global biopharmaceutical company developing innovative medicines in neuroscience and oncology.

Quality Systems Specialist

Wrote work instructions for Veeva Vault (D2E, I2F, DCC, DCR, PR).

Supported validation activities and planning, design qualification, authored/executed test plans and test scripts, discrepancy management, and authored system description and validation summary reports.

Wrote and tested DMS Configuration Test Scenarios for Veeva Vault Sandbox following process flows supplied by Vendor.

Sep 2022 – Dec 2022

Ambry Genetics: Molecular genetics-based healthcare company dedicated to open scientific exchange to understand and treat human disease, providing cutting edge genetic and genomic testing solutions for hereditary cancer and has identified more than 45,000 mutations in 500 genes.

Quality Document Control Specialist II

Managed Veeva Vault launch and training system administration.

Strategized SOP development for document/training issuance, reconciliation/records management, and archival to support GxP ops.

Ensured effective collaboration communication, and teamwork among all departments including R&D, Clinical Laboratory, Bioinformatics, Operations, Clinical Diagnostics and Commercial Operations.

Performed Veeva Vault administrative tasks, assisted in maintenance of controlled documents/controlled records, processing requests, document change controls, archival, filing, scanning, indexing, formatting, set-up, deactivation of personnel, and employee training.

Routine maintenance of Veeva Vault including issuance of new accounts, revised user access levels, and updated system configuration.

Developed/administered training materials as quizzes, evaluations, instructor led courses, On-the-Job training (OJT’s) and creation/revision of employee curricula, in coordination with departmental management, and to align with functional responsibilities in Veeva Vault.

Feb 2022 – Aug 2022

Cytiva Life Sciences (Danaher): Global provider of technologies and services that advance and accelerate the development and manufacture of therapeutics.

Project Documentation Consultant

Worked with Automation Teams/Lead Project Engineers on documentation changes in Innovia (Magic), transferring to Veeva Vault.

Retrieved and moved documents within various eDMS systems as required for projects.

Updated documents to current templates and align with document revisions requested by project leads.

Mar 2021 – Dec 2022

Janssen Pharmaceuticals (Subsidiary of J&J): Manufacturer of prescription pharmaceutical products for general medicine, mental health, neurologics, pain management and women’s health.

Sr. Document Manager/Technical Writer

Supported documentation for Medical Information Contact Center.

Authored GxP SOP’s and Work Instructions in Veeva Vault.

Partnered with IT Business Analysts, CSV/DQ to Review CAPA procedures, version control and document updates and approvals.

Merged Veeva Vault platform with new Learning Management System (Cornerstone on Demand), analyzed process flows, migrated content from Veeva Vault to LMS.

Feb 2022 – Aug 2022

Spacelabs Healthcare: Subsidiary of OSI Systems, offers products & services from patient monitoring and connectivity and diagnostic cardiology.

Sr. Quality Assurance Documentation Specialist

Maintained Quality System procedures, system improvements, change orders and training.

Implemented procedures, documents, work instructions, templates, release requirements, and forms.

Supported Global Document Control to all geographies as SME.

Coordinated business activities associated with Oracle Agile PLM and ECO’s, assured ECO’s properly filled out and changes were identified.

Lead on Spacelabs Change Control Board for Quality Systems.

Mar 2022 – Jul 2022

Imago BioSciences: Clinical-stage biopharmaceutical company focused on discovering and developing novel therapeutics for the treatment of blood cancers (targeting epigenetic enzyme, LSD1 for cancer therapy).

Document Control Project Manager

Coordinated efforts within QA group and worked with multiple functional areas including Clinical Ops, CMC and RA.

Performed gap analysis on SOP’s and Identified Cross-functional issues

Reviewed/approved documents, ensure GxP compliance in SharePoint.

Created document management system in SharePoint for new, in-process and retired documents, assigned doc numbers and revision numbers.

Feb 2022 – Jul 2022

Amicus Therapeutics:

Next-Generation Genetic Medicine Biotechnology Company in Rare Diseases

SOP Document Process Manager

Supported build of electronic QMS Documentation/Training, VQR/Supplier Quality Audits and Change Control programs.

Created SOP’s and processed through document management.

Coordinated transition of required documents to SharePoint.

Coordinated and processed Non GXP and GXP policies/documents.

Creation of QA Policies/SOP’s with QA Team (QMS, GMP Operations, CSV, Gene Therapy Specific SOP’s, etc.).

Jan 2022 – May 2022

Sarepta Therapeutics: Commercial stage biopharmaceutical company dedicated on the discovery and development of precision genetic medicine to treat rare neuromuscular diseases.

GxP Document Control Administrator/Data Migration Expert (IT)

Supported critical initiative: Global GxP electronic Quality Management System (ETQ Reliance) with Veeva Vault.

Partnered with Document Control & Data Migration teams to align documentation and metadata fields between applications.

Maintained data loader spreadsheets, completed workflows, superseded versions, change control records, & periodic reviews.

Ensured attachments and historical versions remain intact.

Identified document types that were not mapped to future types.

Drove to resolution any identified data gaps.

Sep 2021 – Dec 2021

Prestige Consumer

Healthcare:

Markets and distributes over-the- counter healthcare and household cleaning products.

Quality Assurance Manager

Worked with Suppliers/Managers to complete documents and APR’s.

Wrote/Updated Quality Agreements, uploaded supporting documents to Master Control for closure.

Managed Change Requests, CAPA’s and NCR’s.

Jan 2021 – Oct 2021

Regeneron Pharmaceuticals: Biotechnology company focused on neurotropic factors and Regenerative capabilities including COVID-19 Serum

QA Equipment Validation Analyst

Worked with computer services validation group/IOPS.

Preformed equipment validations and periodic review of all lab equipment including equipment tracking and Change Control to comply with IOPs cGxP’s (GMP, GDP etc.) and with Local, State and Federal regulatory requirements.

Mar 2020 – Dec 2020

Alexion Pharmaceuticals:

Global biopharmaceutical company focused on developing and delivering life-changing therapies for patients with devastating and rare diseases.

Quality Assurance Specialist IV - Lead

Lead 9 employees in GxP/Quality Systems/Regulation Processes/Document Compliance Review internationally.

Maintained GMP/GLP archive, retention schedules, outreach to other internal/external archival support staff, acquisition of archive records.

QA review/approval of SOP’s, QI’s, CAPS’s/Deviations in TrackWise.

Generate weekly and monthly metrics.

SME for FirstDoc transition to Veeva Vault.

Retrieval of off-site records for internal requests, agency inspections.

Coordinate documents as laboratory notebooks, binders, procedures, technical reports, audits, records, validation documents and COA’s.

2017 – 2020

PROFESSIONAL FULL TIME WORK EXPERIENCE

Immucor (formerly Gen-Probe/Hologic):

Leader in transplant diagnostics providing molecular and antibody-based assays to evaluation HLA

compatibility between donors

and recipients.

QA Specialist III/Site Document Control Officer (DCO)

Ensured compliance with standards/regulations through process review, approval, auditing and systematic maintenance of the QMS.

Enforced Change Control through review/assessment of document requests to ensure compliance and accuracy.

Established Q-Pulse (QMS) and moved paper system into an electronic one. Wrote user manuals and trained site on the use of the QMS.

Worked with PDP teams, activated site documents (100-200/month).

Provided label control/design/release for production/in-process labels.

Instituted label bar coding per UDI, saving costs of hiring a vendor.

Product release, batch record review, label dispense, validation review.

QA auditor (internal/external), ran war room during site inspections.

2010 – 2017

ADDITIONAL EXPERIENCE

Working Mother/Homemaker – Brewster, NY

Logistics of a Family of 5 Problem Solving Referee Magician Social Worker Care Giver Taxi Driver Parenting Master Scheduler Finances Time Management Skills Disaster Prevention Health Advocate Bank

2002 – Present

HeadClicks, Inc. – Stamford, CT (Global Importer/Reseller).

E-Commerce data-driven marketplace focused retailer selling consumer products on global leading platforms.

QA/Regulatory Consultant

2017-2018

SCA Pharmaceuticals (Sterile Compounding of America) – Windsor, CT

QA Lead/Quality Engineer – Responsible for Site Licensing

2017-2017

EBay Power Seller Business with Virtual Store – Brewster, NY

Ad Writing Photography Shipping Customer Service Supply Management Feedback

2002 – 2010

Sole Proprietor/Photographer/Graphic Designer for Childsplay Designs

Digital Imagery Photography Graphic Designer Time Management Skills Original Designs

2002 – 2010

EDUCATION

Bachelor’s Degree in Chemistry, State University of New York College at Purchase, Purchase, NY

University of Life – Pursuing Doctorate

INTERESTS AND ACTIVITIES

St. Bernard Rescue, Dog Training/Rescue, Macaw Parrots, Koi fish and Ponds, Photography, Graphic Design, Gardening, Disney & Marvel.

Contact this candidate