David Frear Email & Phone Number

Irvine, Ca

Reporting to Manufacturing Engineering - Validate and maintain LabWare LIMS as a global system.

Irvine, Ca

Reporting to the QC Department. Implement new LIMS (LabWare) solution to replace existing (SQL-LIMS) system.

Irvine, Ca

Used my technical abilities, experience, and imagination to solve technical and systemic problems within SAP. Evaluated new processes in Development testing environment, validate system changes in QA environment and document validation testing in HP Application Lifecycle Management (HP ALM). Initiated system and business process changes for various departments and processes. Supervisor: Robert Bales, Production Manager III

Irvine, Ca

As first and third shift supervisor of Fill/Cap/Label, I had 13 direct reports and 3 indirect reports. My responsibilities were to lead teams on first shift in filling, freeze drying, capping and labeling over three product lines. This required scheduling with planners of the individual product lines to ensure resourcing availability to meet these production schedules. As first shift supervisor I also represented the department in most operational functions of the business. These included… Show more As first and third shift supervisor of Fill/Cap/Label, I had 13 direct reports and 3 indirect reports. My responsibilities were to lead teams on first shift in filling, freeze drying, capping and labeling over three product lines. This required scheduling with planners of the individual product lines to ensure resourcing availability to meet these production schedules. As first shift supervisor I also represented the department in most operational functions of the business. These included creating and reviewing document change requests effecting the department; representing the department in the regular scheduling, quality review and dispatch meetings, as well as being responsible for any corrective actions assigned to the department. Supervisor: Dan Meyers, Manufacturing Manager III Show less

Irvine, Ca

My responsibilities included managing all non-conforming product reports (NCR), device history record review, finished product release, in-house label printing, manufacturing and component inspection. As part of NCR management I conducted regular Material Review Board (MRB) meetings to review and facilitate the disposition of non-conforming materials. I supervised 5 Technical Associates over 2 shifts that were responsible for filling and packaging process inspection as well as incoming… Show more My responsibilities included managing all non-conforming product reports (NCR), device history record review, finished product release, in-house label printing, manufacturing and component inspection. As part of NCR management I conducted regular Material Review Board (MRB) meetings to review and facilitate the disposition of non-conforming materials. I supervised 5 Technical Associates over 2 shifts that were responsible for filling and packaging process inspection as well as incoming component and labeling inspection and release. I also managed 3 QA Specialists and a Manufacturing Associate that were responsible for batch record review and finished product release, NCR data management and in-house label printing. I played a key role in vendor and surveillance audits representing these activities to auditors for the facility. Supervisor: Jaime Rubio, QA Managerre Show less

All aspects of quality assurance and quality control were my responsibility. This included, but was not limited to: raw materials, labeling, production formulations, packaging, testing protocols, document change control, final review of product devise history records, internal quality audits, ISO and FDA audits. I was also responsible for preparing all the testing protocols, Excel template worksheets and standard operating procedures pertaining to quality assurance and control. I was a key… Show more All aspects of quality assurance and quality control were my responsibility. This included, but was not limited to: raw materials, labeling, production formulations, packaging, testing protocols, document change control, final review of product devise history records, internal quality audits, ISO and FDA audits. I was also responsible for preparing all the testing protocols, Excel template worksheets and standard operating procedures pertaining to quality assurance and control. I was a key reviewer of all documents and SOP’s for the manufacturing facility. Laboratory operations, instrument maintenance and service were also my direct responsibility. Direct reports were; a QC supervisor, 5 chemists, one document control officer and an internal service technician. I also assisted in operational functions in the absence of the director of operations.• QC/Product Support Chemist April 1994 to April 1995This position was responsible for the laboratory aspects of technical support. It involved the investigation and validation of customer inquiries of reagent performance. While in product support I was also responsible for new and existing product reformulation and development. This included reagents, controls and standards. I was responsible for preparing all specifications for reformulations and developed products including, quality standards and standard operating procedures. • Technical Service Representative February 1991 to April 1994In-house phone support for chemistry reagents and instrumentation. This position also required assisting telemarketing with contacts and requests form sales department. I was in charge of tabulating performance data from customer sites for peer group reference comparison. Documented instrument and reagent complaints, confirmed reagent performance in the lab. Show less