Theresa R. Doran Email & Phone Number

San Diego, California, United States

Carlsbad, California, United States

• Document Control: Actively created document and bill of material lifecycle processes, document and bill of material creation, revision control, periodic review, approvals, and retirement processes. Implemented initial.
• Appointed QA contact for contract clients providing regular communication to Client Management, Operations, QA/QC, and R&D on customer requirements. Partnered with clients and internal team on documentation requests.
• Actively investigated Customer Complaints collaborating with clients, functional departments, co-manufacturer/packers on RCA, risk analysis investigations to ensure timely resolution. Updated customer complaint database.
• Facilitated CAPA investigations from issue identification through implementation of solution and effectiveness monitoring.
• Program managed and participated in the internal, external, regulatory (FDA, TGA), and client audit programs, approx. 10 audits annually.
• Partnered with QA team on implementation of the Supplier Qualification Program. Increased the volume of Supplier Questionnaires distributed to ten a month increasing the number of Suppliers qualified by over 30%.

Carlsbad, CA

• Assisted Head of Quality to establish, implement, and maintain Quality Systems.: Change Control, Non-Conformance Material Report, Corrective Action/Preventive Action, Deviation, Defective Material Report processes.
• Performed data analysis on inspection and kitting processes, collaborated with key departments to implement process improvements and provided training to team members on processes.
• Performed Quality inspection on received product, reviewed batch records, investigated non-conformances, and released product in ERP system.
• Provided Supplier, Third Party Manufacturer, and product complaint metric reports to management. Data assisted in the justification of a Packaging Engineer and changes in Suppliers and Third Party Manufacturer’s.
• Partnered with Formulation and Development Department and Third Party Manufacturer in the implementation and approval of certificate of analysis, bill of material, and manufacturing instruction templates to ensure.
• Managed the review and approval of the Promotional Literature process. Collaborated with department members to transfer responsibility to Regulatory Affairs to streamline process.

Carlsbad, CA

• Ensured the timely and accurate processing of Change and Design Control. Created and revised SOPs for the certification of ISO 13485. Created a spreadsheet of SOPs in Pilgrim SmartSolve to track creation of SOPs for.
• Created bill of materials in MRP system.
• Reviewed and approved finish good batch records ensuring immediate release of product.
• Consolidated master files into one central location on the shared folder.

Temecula, CA

• Millipore (Document Control Supervisor): 2007 - 2011Serologicals (Document Control Supervisor/ QA Project Specialist): 2003 -2006Chemicon International (Document Control Clerk/ Lead): 1999 - 2002
• Selected, evaluated, and mentored five direct reports to ensure efficient operation of Document Control.
• Program managed manual document management system and electronic document management system (EDMS). Coordinated effective handling of documents from start to finish providing preliminary QA technical document review..
• Implemented and program managed process to track, review, store, and access with 24 hours product batch records.
• Performed product release review and entered transaction into ERP system.
• Responsible for ensuring labeling documents were posted to the web and available to customers. Labeling documents posted to web within twenty-four hours.

Temecula, CA (Acquired By Millipore)

• Selected, evaluated, and mentored direct reports to ensure efficient operation of Document Control.Processed change controls, maintained quality records, posted labeling documents to the web, and performed process.
• Implemented digital imaging for kit layouts. Wrote procedure, process flow chart, and trained personnel.
• Cut processing time of USDA Export Certification by 50% by submitting electronic certificates to USDA via e-mail. Collaborated with key departments on animal origin matters. Wrote procedure and trained personnel. USDA.
• Created an electronic tool to manage and streamline labeling for posting to the web. Wrote procedure, created process flow chart, and trained personnel.
• Quality Assurance liaison during ERP migration from Fourth Shift to SAP.
• Collaborated with IT to implement a web-based database that stored documentation and printed documents for point of shipment. Wrote procedure and process flow chart. Trained personnel on procedure.

Temecula, CA (Acquired By Serological)

• Managed Document Control Processes: issuance and tracking of controlled documents and bill of materials, coordination and effective handling of documents through origination, editing, sign off and closure; development.
• Performed product configurations by ensuring accuracy of bills of material using ERP system
• Filed, maintained, and archived Quality System Records e.g. lot history batch records, device master records, and laboratory notebooks.
• Developed electronic Certificate of Analysis (COA) Procedure decreasing COA accessibility lead time for departments and customers.
• Created an Access database for Hold, Master Labels, and Deviations.
• Reviewed lot history batch records.

Associate Of Science - As, Business Administration

Certificate Of Program Completion, Medical Device

Introduction to the Medical Device Industry Fundamentals of GMP and QSR Technical Writing 101 for Medical Device Industry Quality System.