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document control qa qc resume example with 12 years of experience

Jessica Claire
  • Montgomery Street, San Francisco, CA 94105 609 Johnson Ave., 49204, Tulsa, OK
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
  • :
Professional Overview

Extensive experience in essential document collection, review, maintenance and auditing study files. Background includes 10 years experience in FDA regulated environment with experience in both paper and electronic study files. Recognized as a dedicated team player, taking on additional tasks in support of company needs.

Work Experience
Document Control QA/QC, 01/2014 - 01/2015
Honeywell Boulder City, NV,
  • Perform all duties associated with document change control, to include creation of new documents, revise existing documents, obsolete outdated documents, and ensure that all documents are handled in a controlled manner.
  • Responsibilities:* Document Control Assemble Document Change Order packages Incorporate revision comments Ensure version control for all documents and forms Make effective and distribute controlled documents Perform technical writing function as required Lead or support document control systems improvements Order packages Incorporate revision comments Ensure version control for all documents and forms Notification of new approved documents Perform technical writing function as required Assist department head with revision to internal Document Control Leadership Emphasize importance of quality cGMP compliant documentation to coworkers Act as a trusted and valuable resource Provide a positive reinforcing, open learning atmosphere Set a good example in observance of cGMP Supervise employee training in Quality Assurance responsibilities and cGMPs Provide career development for staff Evaluate employee efficiency and productivity Comply with cGMP Documentation Record information accurately Make corrections in a timely manner Check all necessary calculations Review pre-recorded data for accuracy and completion Ensure all entries are neat and legible Follow up on documentation errors Comply with cGMP Practices and Regulations Job Description Generate clear and concise labels for materials and final product Understand, observe, and practice proper gowning Understand flow of personnel in the manufacturing areas.
  • Compliance with safety guidelines Compliance with Policies and Regulations Compliance with 21 CFR - Parts 11, 210, 211, 600, 601, 610 * Compliance with SOPs and other applicable controlled documents Compliance with Quality Agreements Customarily and regularly exercises discretion and independent judgment in the performance of the duties described above.
  • Other duties as assigned.
Document Control Specialist II, 01/2008 - 01/2014
QUINTILES City, STATE,
  • Function as Team Lead for records management projects.
  • Ensure project deadlines, commitments, and goals are met by monitoring team's daily outputs.Train team members on records management tasks, policies, and procedures.Coordinate the retrieval of records requested by users and prepare closed studies for transfer to final destination within agreed timelines.
  • Conduct and manage imaging/scanning processes and train staff on imaging/scanning processes.
  • Interface with departments to support retrieval projects and ensure information needs are met.
  • Serve as primary contact for internal and external clients.Maintain records center security to protect record integrity by ensuring compliance to SOPs.Design and administer records management systems and processes.
  • Record retention, archiving and file box review.
  • Responsibilities:* Ensure effective security, storage, and retrieval of all proprietary and client information in accordance with established procedures, includes usage of scanning equipment.
  • Conduct imaging/scanning and train on imaging/scanning processes Provide reference services to internal clients in accordance to SOP's and by maintaining accurate charge-out systems.
  • Sort and classify coded material for filing.
  • Create files according to established classification system Coordinate work flow through assignment of tasks and establishment of procedures File maintain and process reports, collections and validations Maintain logs and indexes to provide status of information and assist in the collection of data for preparation of monthly metric reports.
  • Assist in the training of new team members on departmental procedures* Scan all closing study files in preparation for archiving & record retention* Create PDF files of all documents that meet record retention requirements Add all appropriate information into data base and schedule pickup of all files, boxes needing to be archived.
Clinical Associate II, 01/2002 - 01/2007
BIOGEN IDEC City, STATE,
  • Establish & maintain practical medial filing systemFile product, protocol and investigator documents in a timely mannerPerform internal auditsEstablish and maintain secure systems for CT scan and archival and retrievalEstablish and monitor procedures to ensure tracking and return of all documents for clinical study reportsSupport clinical documentation in assembling documents for clinical study reportsEstablish and maintain security procedures for all CMF documentsDevelop electronic filing and document systems to provide controlled, efficient, and manageable growth of the CMF tracking systemsScan, index and assign attributes for entering documents into DocumentumResponsibilities:* Ensure effective security, storage, and retrieval of all proprietary and client information in accordance with established procedures.
  • Scan all incoming documentation for all clinical trials.
  • Upload and make all documentation available in Jessica Claire resumesample@example.com Page Three brass doc base with proper attributes.
  • Update appropriate binders with up to date with current SAE.
  • Provide reference services to internal clients in accordance to SOPs and by maintaining accurate charge-out systems.
  • Create and update all SOP binders for all Employees in San Diego Site.
  • Sort all documentation for filing.
  • Create files according to established classification system.
  • Maintain log and enter metadata in database to track status and facilitate accurate retrieval of information.
  • Coordinate work flow through assignment of tasks and establishment of procedures.
  • File and maintain reports, collections, and validations.
  • Maintain logs and indexes to provide status of information and assist in the collection of data for preparation of monthly reports.
  • Assist in the training of new team members and users on microfilm and imaging equipment and departmental procedures.
Education
Diploma: , Expected in
-
Mount Miguel High School - Spring Valley, CA
GPA:
Status -
Skills
clinical study, clinical trials, closing, concise, client, clients, version control, data base, database, Documentation, employee training, filing, forms, imaging, Leadership, Team Lead, materials, neat, PDF, personnel, Policies, processes, Quality, Quality Assurance, Maintain records, safety, San, scanning, SOP, technical writing

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Resume Overview

School Attended

  • Mount Miguel High School

Job Titles Held:

  • Document Control QA/QC
  • Document Control Specialist II
  • Clinical Associate II

Degrees

  • Diploma

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