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Document Control Administrator Resume Example

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Jessica Claire
  • Montgomery Street, San Francisco, CA 94105
  • H: (555) 432-1000
  • C:
  • resumesample@example.com
  • Date of Birth:
  • India:
  • :
  • single:
Summary
18 years in Quality Assurance in Nutraceutical, Medical Device, and Automotive background with proven leadership, organization and project completion skills. 14 years internal auditing at multiple sites with exposure to third party and FDA audits.
Accomplishments
  • Implemented Reduced Inspection Program resulting in a 50% reduction in time to inspect incoming products.
  • Increased efficiency of records storage by restructuring Design History files (over 9000 records.).
  • Researched, identified, and removed (over 14,000) obsolete MRP entries.
Skills
  • Guest services
  • Inventory control procedures
  • Merchandising expertise
  • Loss prevention
  • Cash register operations
  • Product promotions
Experience
Document Control Administrator, 08/2015 to Present
Ampere Computing , ,
  • Performs documentation control activities for document system including writing and releasing new documents, review current SOPs for accuracy, copy control, maintaining electronic files, tracking document revision histories, and archiving obsolete documents.
  • Maintains database of information including all document numbers, dates and distribution requirements.
  • Generates logs, indexes and distribution lists as required.
  • Assures all documents are reviewed for continued compliance to cGMP's and company policies on a periodic basis.
  • Maintains Quality Group documents, including Certificates of Analysis (C of A), Master Batch Records (MBR) and Master Material Records (MMR).
  • Reviews all Master Batch Records for accuracy and issues all Production Batch Records to the manufacturing department according to the production schedule and special requests.
  • Tracks the issuance of all deviations to ensure FDA compliance through completion and provide trending reports to Management.
  • Coordinates and tracks all in-house training of company staff.
  • Completes all vendor related rejection documentation as needed.
  • Project Management.
  • Manage Change Control process to include initiation, review, tracking to ensure deadlines are met and completion.
  • Chair bi-weekly Director meetings to discuss all site pending changes.
  • Interface with all departments daily to collect results and report project status.
  • Monitor workflow and make timeline adjustments as needed.
Quality Technician V / Supplier Quality Assistant, 06/2003 to 08/2015
Saic Germantown, MD,
  • Qualified Compliance Internal Auditor for B&L.
  • Perform and manage all facets of Supplier Reduced Inspection Program to include reviewing non-conformance issues.
  • Collect, analyze data, and maintain Quality Rated and Approved Supplier lists.
  • Review Device History Records for completion.
  • Support St.
  • Louis plant evaluations by researching multiple systems and documentation.
  • Coordinate sample submission process and interface with external suppliers on complaints.
  • Create, update, and follow Standard Operating Procedures.
  • Daily interface with Purchasing and Manufacturing areas.
  • Collect, review and approve documentation for new purchased products.
  • Ongoing management of supplier/part relationships using AS400 ERPLx.
  • Continual improvement through research in ERPLx (MRP system) to eliminate obsolete items.
  • Heavily utilize software programs such as Microsoft Office, SharePoint, Documentum, ERPLx, Catsweb, Qlikview, and PeopleSoft for research and data entries.
  • Collect and analyze data for Management.
  • Department notification of all revision changes.
  • Analyze data and report departmental complaint trends monthly.
  • Assist in the initiation and completion of supplier risk assessments.
  • Receiving, inspection, and evaluation of complaint returned products.
  • Work on special projects.
  • Knowledgeable in ISO, FDA, and GMP standards and regulations.
Document Quality Control Specialist, 09/2000 to 05/2003
Ascension Health Valdosta, GA,
  • Development and control of all PPAP (Production Part Approval Process) submissions for GM, Ford, Chrysler and Mitsubishi to include work instructions, SOP's, Blueprints, and customer specifications.
  • Development of work instructions for manufacturing floor.
  • Daily interface with all departments.
  • Assisted Quality Assurance Manager in performing daily quality functions.
Surgical Assistant, 03/1988 to 09/2000
Humane Society Of Missouri City, STATE,
  • Performed instrument-processing, prepared operating room, sterilizing/disinfecting of instruments necessary for operation.
  • Observed vital signs, checked charts and assisted the surgical team in gowning.
  • Applied correct methods of aseptic technique and adhered to Standard Universal Precautions.
  • Created and maintained a sterile field.
Education and Training
Associate Degree: Applied Science Business Management, Expected in December 2012
to
Jefferson College - Hillsboro, MO
GPA:
Applied Science Business Management
Oriel Stat A Matrix: , Expected in October 2012
to
- ,
GPA:
*ISO 13485 Internal Audit Training *Lead Audit Training: , Expected in November 2014
to
- ,
GPA:
* Perry Johnson: , Expected in 2001
to
- ,
GPA:
TS-16949 Internal Audit Training: , Expected in
to
- ,
GPA:
Skills
AS400, aseptic technique, Blueprints, bi, C, charts, database, documentation, Documentum, GMP, Inspection, Internal Auditor, Internal Audit, ISO, Director, meetings, Microsoft Office, SharePoint, MRP, PeopleSoft, policies, Project Management, Purchasing, Quality, Quality Assurance, Receiving, researching, research, SOP, vital signs, workflow
Activities and Honors
Additional Information
  • Awards and Honors: *Bausch + Lomb Outstanding Performance Achievement Award *A.A. Cum Laude

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Resume Overview

School Attended
  • Jefferson College
Job Titles Held:
  • Document Control Administrator
  • Quality Technician V / Supplier Quality Assistant
  • Document Quality Control Specialist
  • Surgical Assistant
Degrees
  • Associate Degree
  • Oriel Stat A Matrix
  • *ISO 13485 Internal Audit Training *Lead Audit Training
  • * Perry Johnson
  • TS-16949 Internal Audit Training