Experience

Lyophilization Technology, Inc

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• QA Documentation Specialist

  • Jun 2020 - Present



G&W Laboratories

• United States
• Pharmaceutical Manufacturing
• 100 - 200 Employee

• Senior Technician

  • Apr 2015 - Jan 2020

  • Coordinate Master Batch Record processing for all Validation/Technical Services in Qumas according to established formatting requirements; tasks include initiate, revise and route for approval• Initiate review workflows in both TrackWise and QUMAS for approval of documents• Assure documents are complete, accurate, and have supporting documentation• Communicate with Third Party personnel to assure their approvals are received in a timely manner• Provide reports to support the Annual Product Quality Reviews• Assist in reviewing/revising departmental SOPs, Work Instructions and Forms• Conduct bi-weekly Batch Record meetings• Monthly metrics and reports in an Excel spreadsheet• Prepare control charts• Manage overdue records report• Biennial reviews• Build quizzes for SOP’s through Compliance Wire

• Documentation Specialist II

  • Apr 2015 - Jun 2017

  • Coordinate Master Batch Record processing for all Validation/Technical Services in Qumas according to established formatting requirements; tasks include initiate, revise and route for approval• Oversee detailed document tracking process and monitor workflows to ensure timely and on-schedule completion • Generate Master Packaging Batch Report in Oracle• Manage the workflow in Trackwise to generate change controls and reports and to complete final team approvals• Training in Standard Operating Procedures in Compliance Wire



Teva Pharmaceuticals

• Israel
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Documentation Specialist

  • Nov 2007 - Apr 2015

  • Managed initiation and revision of all Master Batch Records for Validation & Technical Services and Package • Generated change control reports and completed final team approvals in Trackwise• Routed all documents for audit, review, and approval in Master Control• Maintained all MRC files, including tracking and filing in MRC database, and prepared reports in the Master Record • Tracked and filed in MRC database, distributed cc list, performed closeout, and finalized completion • Created work instructions for Master Packaging Batch Records



Johnson & Johnson Cordis Corporation (Kelly Services)

• Fulfillment Coordinator

  • Oct 2006 - Oct 2007

  • Provided support to 2 managers and Director of Medical Communication. • Data entry input of Medical Information request• Handled fulfillment of medical letters• Created Purchase order requisitions. • Maintained version control for all standard letters and presentations• Updated Medical Communication Intranet Homepage• Maintained all current standard medical letters in an electronic file• Trained new coordinators • Provided support to 2 managers and Director of Medical Communication. • Data entry input of Medical Information request• Handled fulfillment of medical letters• Created Purchase order requisitions. • Maintained version control for all standard letters and presentations• Updated Medical Communication Intranet Homepage• Maintained all current standard medical letters in an electronic file• Trained new coordinators



GlaxoSmithKline (Kelly Services)

• Document Prep Support

  • May 2006 - Oct 2006

  • Sorted and filed batch records, verified forms and • Sorted and filed batch records, verified forms and