Document Control Specialist


Mary Maldonado


1229 Lincoln St. Longmont, CO 80501


970-631-3257


maldonadomaryann1@gmail.com


 skills



 



  • Enthusiastic and well-organized Document Control Administrator with solid background in Document Control fundamentals within a Medical Device environment

  • Agile, SAP, PDM, EDMS, Sytline, MS Windows proficient, Access

  • Relentless drive to prioritize work load to ever changing demands deadline-driven

  • Accurate and detailed

    • Customer service-oriented




 



Experience



 


11/14-06/15                                      PharmaJet                                        Golden, CO


Document Control Specialist


Medical Device Needle-free Injection System



  • Manage the (DCO) Document Change Order process specifically PharmaJet’s website in accordance with customer and company requirements. This includes labeling review for all promotional and marketing material. Proof reading and editing (if required) before routing for review and approval of


       trade show graphics, posters, press releases, emails, handouts, presentations, videos, surveys, 


       flyers, specifications, products lists, drawings, (SOP’s) standard operating procedures, third party    


       document review reports, clinical reports



  • Maintained employee training records

  • Audit and maintain a secure controlled electronic and paper filing system

  • (CCB) change control board agenda and meeting minutes


 


6/12-9/13 -Various temporary positions


Document Control Specialist


 


09/13-11/13 (Reglera) Outsourcing


06/13-07/13 (Amgen) Pharmaceutical


06/12-02/13 (Beckman Coulter) Life and Science


 


 


11/07-10/11                                      Otologics                                          Boulder, Co


Document Control Specialist      


Medical Device Implantable Hearing Aide



  • Managed the (ECO) Engineering Change Order and (MCO’s) Manufacturing Change Order process using Agile database. Generated and reviewed ECO’s / MCO’s packages for accuracy and completeness to be in compliance with the integrity of the Quality Management Systems procedures and processes.  Routed all new / revised changes for approval per approval matrix

  • Upon approval documents were updated in Word, Excel and or Visio, drawings were assigned to the appropriate drafter

  • Assigned Engineering Lab Notebooks

  • Created and updated (BOM’s) Bills of Material

  • Maintained controlled (SOP) binders for two buildings (total of 4)

  • MRB (Material Review Board) coordinated Non-Conforming Material routing and obtaining approvals, notified affected department managers of status to closure

  • TDA (Temporary Deviation Authorization) assigned TDA numbers, maintain logs (electronic and manual), notified affected department managers of expiration dates  and or extensions to closure

  • Ensure all records (electronic and manual) contain the most current and historical revision

  • Provide appropriate (SOP) training for employees electronically

  • Maintained training records for US and international employees including doctors and surgeons

  • Responsible for and controlled Device History Records in a strict manner

  • Achieving and retrieval of all company records

  • Regularly audited both electronic and paper filing system.


 


06/06-11/07                                      Crosstrees Medical                      Boulder, Co


Documentation Control Specialist


Medical Device Cement Spine Delivery System



  • DCN’s (Document Change Notices) Maintained electronic document system including  documentation drawings, standard operating procedures, and work instructions and training records

  • Receiving / inspection of all incoming parts

  • Maintained employees training records

  • Kitting and packaging

  • Set up and maintained inventory, calibration schedules for instruments and equipment

  • Approved suppliers list, pest control and facility cleaning services

  • Purchasing


 


04/00-07/04                                      Maxtor Corporation                      Longmont, Co


Engineering Change Analyst         


Disk Drive



  • Generate and implemented ECO’s and MCO’s using PDM database

  • Routed and tracked ECO’s and MCO’s for approval

  • Obtained approvals for new/revised engineering, quality and production documentation

  • Interfaced with Engineering, program management worldwide documentation personnel and others as required, on documentation records and issue resolution this included Singapore and China

  • Maintained electronic document PDM system consisting of product related documentation, drawings, standard operating procedures, work instructions, and customer supplied documents

  • Created and maintained Bill of Materials

  • Intermediate departmental and corporate database entry

  • Facilitated (CCB) Change Control Board meetings and minutes weekly

  • Trained Singapore counter partners in Processing ECO’s and MCO’s successfully to transfer workload to them


 


05/92-04/00                                     Rela (HEI)                                         Longmont, Co


Document Control Specialist        


Medical Device Contract Manufacturing



  • Release and maintenance of all ECO’s, verified ECO package for accuracy and completeness and integrity of affected documentation including specifications, drawings, bom’s, procedures customer unique configurations, corporate quality records , device master records, device history records processed engineering change orders

  • Managed accurate and secure electronic and paper document system using Sytline

  • Created and updated Bills of Materials

  • Provided and maintained controlled documents for GMP controlled builds to manufacturing as well as purchasing

  • Trained other document control specialist


 



Education



GED


 


  



Skills



 



  • Enthusiastic and well-organized Document Control Administrator with solid background in Document Control fundamentals within a Medical Device environment

  • Agile, SAP, PDM, EDMS, Sytline, MS Windows proficient, Access

  • Relentless drive to prioritize work load to ever changing demands deadline-driven

  • Accurate and detailed

    • Customer service-oriented




 



Experience



 


11/14-06/15                                      PharmaJet                                        Golden, CO


Document Control Specialist


Medical Device Needle-free Injection System



  • Manage the (DCO) Document Change Order process specifically PharmaJet’s website in accordance with customer and company requirements. This includes labeling review for all promotional and marketing material. Proof reading and editing (if required) before routing for review and approval of


       trade show graphics, posters, press releases, emails, handouts, presentations, videos, surveys, 


       flyers, specifications, products lists, drawings, (SOP’s) standard operating procedures, third party    


       document review reports, clinical reports



  • Maintained employee training records

  • Audit and maintain a secure controlled electronic and paper filing system

  • (CCB) change control board agenda and meeting minutes


 


6/12-9/13 -Various temporary positions


Document Control Specialist


 


09/13-11/13 (Reglera) Outsourcing


06/13-07/13 (Amgen) Pharmaceutical


06/12-02/13 (Beckman Coulter) Life and Science


 


 


11/07-10/11                                      Otologics                                          Boulder, Co


Document Control Specialist      


Medical Device Implantable Hearing Aide



  • Managed the (ECO) Engineering Change Order and (MCO’s) Manufacturing Change Order process using Agile database. Generated and reviewed ECO’s / MCO’s packages for accuracy and completeness to be in compliance with the integrity of the Quality Management Systems procedures and processes.  Routed all new / revised changes for approval per approval matrix

  • Upon approval documents were updated in Word, Excel and or Visio, drawings were assigned to the appropriate drafter

  • Assigned Engineering Lab Notebooks

  • Created and updated (BOM’s) Bills of Material

  • Maintained controlled (SOP) binders for two buildings (total of 4)

  • MRB (Material Review Board) coordinated Non-Conforming Material routing and obtaining approvals, notified affected department managers of status to closure

  • TDA (Temporary Deviation Authorization) assigned TDA numbers, maintain logs (electronic and manual), notified affected department managers of expiration dates  and or extensions to closure

  • Ensure all records (electronic and manual) contain the most current and historical revision

  • Provide appropriate (SOP) training for employees electronically

  • Maintained training records for US and international employees including doctors and surgeons

  • Responsible for and controlled Device History Records in a strict manner

  • Achieving and retrieval of all company records

  • Regularly audited both electronic and paper filing system.


 


06/06-11/07                                      Crosstrees Medical                      Boulder, Co


Documentation Control Specialist


Medical Device Cement Spine Delivery System



  • DCN’s (Document Change Notices) Maintained electronic document system including  documentation drawings, standard operating procedures, and work instructions and training records

  • Receiving / inspection of all incoming parts

  • Maintained employees training records

  • Kitting and packaging

  • Set up and maintained inventory, calibration schedules for instruments and equipment

  • Approved suppliers list, pest control and facility cleaning services

  • Purchasing


 


04/00-07/04                                      Maxtor Corporation                      Longmont, Co


Engineering Change Analyst         


Disk Drive



  • Generate and implemented ECO’s and MCO’s using PDM database

  • Routed and tracked ECO’s and MCO’s for approval

  • Obtained approvals for new/revised engineering, quality and production documentation

  • Interfaced with Engineering, program management worldwide documentation personnel and others as required, on documentation records and issue resolution this included Singapore and China

  • Maintained electronic document PDM system consisting of product related documentation, drawings, standard operating procedures, work instructions, and customer supplied documents

  • Created and maintained Bill of Materials

  • Intermediate departmental and corporate database entry

  • Facilitated (CCB) Change Control Board meetings and minutes weekly

  • Trained Singapore counter partners in Processing ECO’s and MCO’s successfully to transfer workload to them


 


05/92-04/00                                     Rela (HEI)                                         Longmont, Co


Document Control Specialist        


Medical Device Contract Manufacturing



  • Release and maintenance of all ECO’s, verified ECO package for accuracy and completeness and integrity of affected documentation including specifications, drawings, bom’s, procedures customer unique configurations, corporate quality records , device master records, device history records processed engineering change orders

  • Managed accurate and secure electronic and paper document system using Sytline

  • Created and updated Bills of Materials

  • Provided and maintained controlled documents for GMP controlled builds to manufacturing as well as purchasing

  • Trained other document control specialist


 



Education



GED


 


 


 

  • ID#: 104797
  • Location: Longmont, CO , 80501

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