Great Customer service skills with administrative secretarial experience. Motivated QAPI professional with SharePoint-based electronic document management system expertise. Experience formatting and publishing FDA regulatory submissions, business deliverables including presentation slides, proposals and technical reports. Over 10 years of hands-on experience reviewing for conformance of format per the company issued Style Guide Policy.
Microsoft Office proficiency
Meticulous attention to detail
Professional and mature
Strong problem solver
Dedicated team player
Detailed meeting minutes
Executive presentation development
Increased office organization by developing more efficient filing system and customer database protocols.Received a merit raise for strong attention to detail, exemplary customer service and team-player attitude.Successfully planned and executed corporate meetings, lunches and special events for groups of 100+ employees.
03/2016 to Current
Administrative Specialist IIPerformance Improvement Department － Columbia, SC
Provides administrative support to the Performance
Improvement Department to include: filing, typing correspondences and taking
meeting minutes as required.
reports and memorandums, Prepares data reports and sets up equipment for
monthly QAPI Council Meetings.
the Performance Improvement Department with M-300 review for completeness, logs
data on Excel Spreadsheet, and maintains M-300s in an organized filing system.
Routinely enters educational data using the Pathlore System.
Provides support for regulatory and accreditation surveys.
Assists PI staff in making compliance rounds.
Routinely updates and distributes
Facility Directives based upon changes.
Receives and distributes mail and
Answers and screens incoming telephone calls.
Designed electronic file systems and maintained electronic and paper files.
Writes reports and correspondence from dictation and handwritten notes.
Organizes files, develop spreadsheets, fax reports and scan documents.
04/2015 to 03/2016
Patient Access Representative AdmissionsPalmetto Health Richland Children's Hospital － Columbia, SC
Greets patients and their caregivers and records pertinent information into a computer database.
Records insurance information and obtains pre-approval for treatment if needed.
Relays information between patients and other staff members, and provides them with updates as needed.
Prioritizes the order of care so that the most critical patients are seen first.
Keeps paper and electronic medical records, and updates these records as needed.
Provides information to insurance companies in order to assist with billing.
Assists patients during checkout, and ensures they have post-treatment instructions if required.
Refers individuals to outside agencies when unable to meet their needs.
Calculates payment information, accepts funds, and credits accounts accordingly Listens well and devotes full attention to patients and medical professionals alike.
Is compassionate and caring, as the job involves dealing with people who are critically ill or injured.
Has the ability to remain calm, even under the most stressful of situations.
Communicates well, both orally and in writing.
Is able to switch priorities based upon patient need.
Possesses a basic understanding of medical terminology and procedures.
Is able to maintain confidentiality.
Has a professional appearance and demeanor in order to make others feel more at ease.
04/2014 to 04/2015
Document Control Specialist IGlycoMimetics, Inc － Gaithersburg, MD
Works with team to conform to best practices for document
development and management.
Maintains the documentation control system,
including the documents, records and associated processes in accordance with
company, GXP and regulatory requirements.
Performs various duties essential to
the implementation and maintenance of a regulated documentation system,
including coordinating efforts for the control of new and updated systems,
including procedures and practices.
Assists in ensuring the consistency and
quality of the company product, process and policy documentation as it relates
to regulatory/quality/technical operations/clinical development.
central repository, including history files, for all controlled quality and
regulatory documents and records; Interfaces with other staff members to answer
questions regarding SOPs and documentation.
Maintains controlled documents in
strict compliance to corporate policies, regulations and standards.
and publishes reports related to the creation and control of quality system
Facilitates the effective processing of quality system documents
to ensure they are maintained and archived in an organized and retrievable
state (manual or electronic) for accountability and for access by any
Maintains various documents to include, but not limited to:
library of products- and process-related reference standards, regulations,
guidance, clinical articles and journals; Interacts with vendors.
process training for document creation and document control processes; Complies
with all applicable policies regarding health, safety, and environmental
11/2011 to 04/2014
Documentation and Operational Compliance Systems AssociateDynPort Vaccine Company LLC － Frederick, MD
Generate and manage controlled documents.
Tracking documents throughout each of the lifecycles; draft, collaborative authoring, review, approval and finalize.
Responsible for document version control.
Ensure the tracking of all documentation as required.
Maintain archives of all documents; Work with Project Managers to ensure timely, accurate reporting and proper documentation.
Develop/edit various documents including process documentation, SOPs, position descriptions, among others; Convert documents to PDF format and support document workflow.
Responsible for verifying that all documents were complete and compliant with procedures.
Responsible for formatting documents for internal and external customers by editing for quality, accuracy and grammar.
Provide editing and writing support in preparation of reports and customer deliverables and internally written documents; Maintain accurate and secure filing systems for documentation to include current active/effective/published documents, inactive documents and obsolete documents inclusive of the historical information.
Audit master files against the database to ensure accuracy.
Obtain metrics through the use of the database; Write, review and revise Manuals, Policies, Standard Operating Procedures and Direction Sheets.
Assist with GXP training sessions; Work with Quality Manager and Project Managers to define process improvements, ensure compliance and contribute to project and team success.
Recommended changes to quality standards to improve efficiency; Manage documents in the EDMS including, but not limited to formatting, review and approval, finalization and General DOC Systems requests.
Responded to in-depth and quick turnaround inquires; Provide user support, training and documentation for EDMS to staff at all levels of the company, and help trouble-shoot system issues; Assist with GXP Quality Systems including CAPA, Change Control, Deviation/Investigations, Regulated Information Technology Environment Change Control and Label Management; Coordinate computer validation activities to meet 21 CFR Part 11 requirements; Schedule, perform and report on internal quality audits; Assist with office-wide upgrade for Adobe Acrobat Professional versions 9 and 10.
Extensive experience in customer service settings; Making all necessary arrangements for travel, preparing itineraries, making transportation and hotel reservations, and preparing travel vouchers;.
05/2010 to 11/2011
Publications Associate ProfessionalDynPort Vaccine Company LLC － Frederick, MD
Managed the production of all company deliverables
including FDA regulatory submissions, technical reports, scientific posters and
abstracts, and new business proposals.
Provide word processing, graphic design
and editing support; Coordinate production and assembly of all DVC
publications, to include Regulatory Affairs submission, company deliverables
and business proposals.
Established and maintained a system for the deliverable
process to ensure consistency and best practices for the review, approval and
archival of deliverables.
Acted as a single point of contact for internal
Provided version control for routing deliverables for review
and approval in the Electronic Document Management System; Utilized Adobe
Acrobat Professional software to electronically publish multiple documents into
a single PDF file. To include hypertext to create links to relate information
and bookmarks for navigational aids.
Assisted in the creation and maintenance
of the Style Guide and templates to ensure proper format of all publications.
Skilled at Word processing (Microsoft Office), Adobe Acrobat and desktop publishing.
Initiated completion of the document management workflow to meet customer
deliverable timelines and coordination of Style Guide reviews.
tailoring guidelines to functional groups for assistance in the development of
workflows and document templates.
Worked with the graphic designer to provide
graphic design assistance.
Familiarity with print production process and
equipment for in-house production.
Assisted New Business with special and
ongoing projects, including competitor/partner research and assessments.
Provide training to managers and functional groups on publishing and document
management procedures to ensure consistency.
Assisted in the implementation of
systems and processes for generating, editing and validation electronic
02/2008 to 05/2010
Project Administration AssociateDynPort Vaccine Company LLC － Frederick, MD
Assisted Publishing Operations Manager in producing more than 100 complex, technical reports and business deliverables and regulatory submissions.
Provided computer graphics and word processing support, assisted with the creation of business and scientific deliverables e.g. Regulatory Affairs submissions, business proposals, posters, journal articles, manuscripts and slide presentations.
Maintained the deliverable schedule; assisted project managers with scheduling deliverables workflows.
Assisted in the creation and maintenance of a Publishing Operations Style Guide and templates to ensure consistency of all publications; developed Publishing Operations Standard Operating Procedures and Direction Sheets.
Assisted with the coordination, production and assembly of all company deliverables.
07/2006 to 02/2008
Senior Administrative AssistantDynPort Vaccine Company LLC － Frederick, MD
Provided professional administrative support to staff at all levels of the company mainly to the Scientific and Technical personnel.
Completed general office duties including but not limited to, copying, scanning, faxing, filing, scheduling and documenting meeting minutes at technical meetings.
Generated reports and maintained databases and spreadsheets for internal clients.
Managed and coordinated multiple calendars for various technical team members.
Performed literature searches for Chief Medical Officer and Chief Scientific Officer.
Coordinated complex travel arrangements for several large departments.
Coverage of the receptionist desk to include receiving incoming telephone calls and directing callers to the appropriate personnel.
High School DiplomaJohn S. Battle High School － Bristol, TN, United States
Adobe Acrobat Profession
Microsoft Office: Word, Excel, PowerPoint, Access, Outlook and Visio