Experience

DPT Laboratories

• United States
• Pharmaceutical Manufacturing
• 300 - 400 Employee

• Supervisor, Package Engineering

  • Jun 2016 - Present

• Package Engineering Supervisor - Documentation

  • Dec 2015 - Present

  Supervises and provides guidance over the Packaging Engineering Coordinator Group which includes managing document control daily activity, Supporting R&D PKG Engineering Projects, Supporting PKG Engineering Commercial Launch Projects, Revisions to all existing PKG Engineering modules, Revisions/Implementation of all PKG Engineering Component Specifications, standard monitoring and periodic review/assessments as per company policies/procedures and cGMP compliance.

• Documentation Analyst, Package Engineering

  • Aug 2012 - Dec 2015

  • Provides representation for Package Engineering department as it relates to interdepartmental and client needs.• Initiates Change Control for new or revisions to existing cGMP documents (packaging and packaging setup documents). • Develops initial draft of technical documents.• Responsible for generation and revision of packaging modules and packaging setup modules.• Routes and obtains comments for new and modified clinical and commercial packaging modules.• Initiates, tracks and drives QA approval of Trackwise Change Control documents for associated clinical and commercial packaging modules. • Ensures the “on time” review and comments for all associated documentation.• Obtains and implements recommendations/comments from cross-functional panel or reviewers.• Provides technical understanding and insight to the clinical and commercial packaging process and associated modules.• Tracks and drives time lines for deliverables.• Meets with cross departmental representatives, clients and key stakeholders to ensure timely timely turnaround for reviewing and issuing of documents.• Within area of responsibility, understands and complies with all DPT safety, environmental and and quality practices and procedures as outlined in organizational/departmental guidelines and SOPs as well as applicable federal, state and local regulations. Show less

• Quality Coordinator III, Quality Engineering

  • Jul 2011 - Aug 2012

  • Issue Change Control for new or revisions to existing cGMP documents (compounding, filing and and packaging documents).• Support the circulation of and obtain comments to and revise clinical and commercial technical instructions and Master Batch Records/Modules for compounding, filling, and packaging.• Route and obtain comments for new and modified clinical and commercial compounding, filling, and packaging modules.• Ensure the timely review and comments for all associated documentation.• Obtain and implement recommendations/comments from cross-functional panel or reviewers.• Track and drive time lines for deliverables.• Meet with inter departmental representatives, clients and key stockholders to ensure timely turnaround time for reviewing or issuing of documents.• Maintains filling/tracking systems for interdepartmental documentation materials. Archives and retrives documentation material. • Within area of responsibility, understands and complies with all DPT safety, environmental and quality practices and procedures as outlined in organizational/department guidlines and SOPs as well as applicable federal, state, and local regulations. Show less

• Engineering Coordinator, R&D Package Engineering

  • Mar 2007 - Jul 2011

  • Track the operational activities of the support teams.• Act as a liaison between support teams.• Assists in the day-to-day vendor/client interaction.• Effectively enforce project standards.• Ensure project documents are complete, current, and stored appropriately.• Develop and write project engineering specifications (with guidance from Project Engineer or team Manager) that meet the standards set forth by project requirement documents.• Facilitate communication between all support teams.• Review all documentation prepared by other departments before passing on to client.• When needed, collects all documentation for product release and assists in the release process.• Tracks meeting/discussions.• Analyze and document process and problems. Develop solutions to enhance efficiencies.• Coordinate and implement solutions from process analysis and general department projects.• Review issues/concerns from each project with Project Management or team Manager and determines how each problem should be assigned.• Communicates with Project Manager or team Manager on department operations/status.• Assist in the QA of projects as needed. Show less

• Senior Product Development Tech, R&D Product Technical Srvices

  • Apr 2000 - Mar 2007

  This group’s primary responsibility is to provide R & D support for commercial products and focus on the daily maintenance and troubleshooting of products in commercial production. Beginning January 2003, additional responsibilities were added to assist in Process Development and scale up of products.

• Product Development Technologist, R&D Contract Mfg. Support, Formulations Lab

  • Feb 1997 - Apr 2000

  Assists the scientists and participates in the manufacture of pilot batches providing support in the documentation of process parameters, sampling, completion of batch documentation, revision of compounding modules, procurement of QA approvals for batch changes, and batch tracking. Obtains samples, raw materials specifications, methods, and MSDSs from suppliers and clients and initiates part number requests for projects. Conducts physical testing such as pH, viscosity, etc. on product samples when required. Conducts calibration of laboratory instruments to include the pH meter, Brookfield Viscometer, top loader and analytical balances. Obtains information such as stability reports from QIS. Show less

• Compounding Technician

  • Sep 1994 - Feb 1997