ANDRINNE THOMAS

EXPERIENCE:

QA Documentation Specialist I Nov 2022 - Present

Gilead Sciences

Contract California

Collaborates with customers to ensure the correct and timely implementation of customer requests and document processing.

Supports the distribution and maintenance of GxP documentation.

Scans, verifies and archives documentation as needed.

Recommends process improvements and proposes changes.

Provides support with internal and regulatory audits/inspections as required.

May participate in training users for electronic systems (as applicable).

Understand and use document templates.

Supports the maintenance of monthly document control metrics.

Performs general word processing tasks and support. Checks format and conformance to document templates, verifies own work.

Provides additional support and assistance on tasks and projects as directed by management

Participates as required in training on issues affecting own area of work. Notifies manager of compliance questions and issues.

Demonstrates knowledge of Document Control fundamentals, Quality Systems and GMP requirements.

Demonstrates general knowledge of the processes and impact of document control, and the relationship between the document change process and products.

Demonstrates basic understanding of the current pharmaceutical industry and applicable regulations including 21 CFR, GxP, ICH, etc.

Demonstrates working knowledge of Electronic Document Management Systems (EDMS).

Keeps abreast of the basic requirements for compliance in own work area.

Demonstrates a high degree of attention to detail.

Demonstrates problem solving skills.

Demonstrates proficiency in Microsoft Office applications.

Demonstrates strong verbal, written and interpersonal communication skills.

Document Control Specialist Aug 2021 - Nov 2021

Juul Labs

Contract California

Maintain accurate and secure filing systems for documentation using Veeva Vault to include current active/effective documents, inactive documents and obsolete documents inclusive of the historical information.

Format SOP’s/memo’s/policies and reports Management System documents; processing each document through the appropriate review and approval cycles.

Provide end user technical support for the Electronic Document Management System (EDMS) and general document control issues, as needed.

Assign and monitor document numbers and review documents for accuracy and completeness.

Document Control Specialist July 2020 – May 2021

Sanofi Malvern, PA

Maintain and distribute control of master batch records, protocol specific product information files, and production batch records, including the transport across campus thereof, and study information files creation.

Scanning executed batch records and other GMP documentation.

Maintaining the departmental central file room, filing all documents related to projects, such that they are retrievable for internal use of regulatory inspection.

Completing batch documentation history.

Archiving Clinical Supply Chain Operations GMP documentation.

Participating in projects related to the ordering and scheduling group.

Document Control Specialist II January 2018 – March 2020

Charles River Labs Malvern, Pa

Coordinate the revision process of Standard Operating Procedures (SOPs), forms and other controlled documents

Registered, scanned, controlled, distributed, transmitted, and filed project records using Documentum

Correspond daily with external and internal clients regarding Final Reports and handling confidential, time sensitive documents; Audit Client Batch Records for corrections and sending documents to clients for review and approval

Prepared documents for closeout

Monitored the market for backlogs and identified inadequacies

Maintain all roles within Laboratory Information Management System (LIMS) as QA, Sample Processor and Archivist; Issued Final Reports and input data in LIMS for final report release date

Document Control Specialist March 2015 – January 2018

Frontage Labs Exton, PA

●Prepare packages for Turnover within the scheduled time frame.

Registered, scanned, controlled, distributed, transmitted, and filed project records using Documentum Maintained precise and organized filing system

●Prepared documents for closeout.

●Monitored the market for backlogs and identified inadequacies.

●Used standard word processing, spreadsheets, and other office software to support work activities.

●Received, date stamped, and distributed incoming mail, packages, and faxes, to appropriate personnel.

●Prepared FedEx labels and packages, as well as used stamps.com for distribution of outgoing mail.

Stability Assistant December 2003 – April 2014

Shire Pharmaceuticals Wayne, PA

●Assisted in the organization of product stability testing programs.

●Performed stability related functions including tracking of stability pulls and data acquisition.

●Maintained a document control system to organize, file and archive stability data.

●Maintained regular communication with stability contract testing facilities.

●Assisted in the preparation of various ad hoc reports, as assigned, including internal and CMO metrics reports, NDA Annual reports, Product Quality Review Reports, etc.

●Evaluate stability data results to ensure adherence to cGMP guidelines and expectations.

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