Results-oriented Quality Assurance professional with 25 years of diverse experience in the healthcare industry under GxP environments; expert knowledge of quality systems under GxP regulated environments. Strong analytical, leadership and organization skills quality professional with responsibilities including documentation review and approval, batch and critical systems release and document control. Proven ability to work in a fast-paced setting compromised of geographic dispersed teams while being able to multitask in resource and time-limited situations with positive results.

PROFESSIONAL EXPERIENCE

Novartis Gene Therapies, Libertyville, IL. 2022 to 2023

Senior Specialist, Quality Assurance Documentation Quality Systems

Novartis Gene Therapies / (AVEXIS), Libertyville, IL. 2020 to 2022

Supervisor, Quality Assurance Document Control

Manage the GxP Document Control System to ensure compliance with quality objectives & regulatory requirements. Manage the preparation, routing, review, approval, distribution, and archival of new & revised controlled/managed documents. Establish & maintain approved procedures, practices, standards, and requirements associated with the document management systems. Provide staff training for using the document management system (including document management processes & procedures). Support audits (internal & external) to ensure compliance with regulatory & quality requirements. Manage team and process performance management reviews. Mentor and coach team members and stakeholders.

AVEXIS, Libertyville, IL. 2018 to 2020

Document Specialist, Quality Assurance

•Manage the preparation, routing, review, approval, distribution, and archival of new and revised controlled/managed documents.

•Review documents submitted to ensure the correct use of templates, correctly entered metadata and document types.

•Perform advanced word processing and assists AveXis personnel in resolving document format issues.

•Ensure controlled documents are periodically reviewed for relevance and accuracy to ensure actual practices are reflected as defined in applicable procedure.

•Provide guidance and advice on approved procedures, standardization and requirements associated with the document management system.

•Collaborate with cross-functional departments to ensure timely implementation of document change requests.

•Provide training to new staff on document management system and document management processes and procedures.

•Support audits (internal & external) in order to verify that regulatory and quality requirements have been met.

•Deliver exceptional customer service to end users.

•Results-oriented documentation professional (awarded exceptional impact).

•Organize and ensure accurate and reliable filing systems for all paper based GxP documents.

•Advanced word processing and formatting assistance.

•Manage paper and electronic documentation for document management systems.

•Responsible for site records archiving, SOP binders, retrieval, and permanently obsolete decommissioned documentation.

•Customer service tasks associated with administrative support of quality systems.

•Subject Matter Expert for internal and external health authority audits.

•Develop training materials and knowledge assessments for document processes.

BAXTER HEALTHCARE, Round Lake, IL. 2012 to 2018

Sr. Documentation Specialist – QA

Responsible for critical systems disposition and release. Performs final review and release of plant critical systems. Interprets testing requirements and ensures presence and acceptability of all required documentation prior to release.

•Perform quality review for documentation such as plant validation protocols, controlled system work requests and production machine qualifications.

•Perform data entry into a JDE-based system for critical system and batch release. Generate nonconformance reports from the TrackWise 8 NCR/CAPA system.

•Communicate system release status and requirements proactively with internal and external partners and management.

•Maintain file archives such that documents are readily available and meet document retention requirements.

•Support department responsibilities such as batch folder issuance, logbook maintenance, controlled forms and document distribution, filing, compliance audits, 6S, lean initiatives and training.

•Identify opportunities for continuous improvement; initiates projects and writes change requests as needed to implement continuous improvement initiatives.

COVIDIEN / (TYCO KENDALL HEALTHCARE), Crystal Lake, IL. 2005 to 2012

Sr. Documentation Specialist – QA

•Support Document Management Systems.

•Manage documentation/processes/change control from generation to complete (ex: Standard Operating Procedures, batch record and component preparations, Work instruction sheets, validations).

•Coordinate/Administer of document management databases for Corrective and Preventative Actions, Customer Complaints, and Calibrations. Worked with departments to ensure activities and documentation was supported for investigation and implementation.

•Facilitate training to broad audience of users.

•Plant Internal Auditor. Performed process compliance audits of all manufacturing areas to ensure quality of product/process per the regulation and standards applicable to operations.

•Supported FDA, Pharma Partners and Internal Auditors. Perform in war room activities: collect, review data and scribe.

•Maintain appropriate quality metrics for trend analysis.

•Coordinate Management Review and Quality Data Review Meetings; including summaries of the data presented, conclusions, and meeting minutes as required.

•Documented and tracked actions items and follow-up commitments to closure, never missed a deadline.

FERRO PFANSTIEHL LABORATORIES, Waukegan, IL. 2003 to 2004

QA Documentation Administrator / Site Facility Support Coordinator

Responsible for administration of SOP change control systems. Log data, track approval processes, prepare and distribute SOP’s. Writes applicable SOP’s for defining processes used in QA Documentation.

Schedule and coordinate collection of data for, and prepare department reports, & spreadsheets.

Manage administration of office services; to include site cash accounts, office equipment and supplies, and travel.

PFIZER / (SEARLE), Mount Prospect, IL. 1996 to 2003

QA/QC Documentation Coordinator / Site Facility Support Coordinator

Process local document change requests and issues documentation in the electronic documentation management system.

Distribute documentation to physical book locations as required.

Communicate proactively with internal and external partners and management.

Notify plant personnel of new and revised corporate/division/product documentation, reviews and files associated documentation.

SKILLS

Microsoft Office (e.g., Excel, Outlook, PowerPoint, SharePoint, Word Document, MS Access databases, Teams)

Document Management Systems: Documentum, Adaptive Compliance Engine, Agile

Learning Management Systems: UP4GROWTH; ComplianceWire, ISOtrain

HR Management Software: ADP, Workday

Other Industry Software: TrackWise; Maximo; LabVantage, LIMS software, Oracle, SAP

EDUCATION

Stratford Career Institute, Washington, DC – Business Management - 2000

McHenry County College, Crystal Lake, IL – 1995-1997

McHenry High School, McHenry, IL – 1995

Contact this candidate