Patricia O’Marra

adrszy@r.postjobfree.com

520-***-****

Facilitate and coordinate study development and execution; assists in preparation and review of deliverables for diagnostic testing and biomarker analysis for specific projects. Facilitates logistics of a harmonized sample process flow (between Clinical Sciences Management (CSM), Bio-Sample Management (BSM), Histology, and Pathology) and assists in preparation and proactive communication of Turn Around Time (TAT) reporting and project deliverables. Assist in preparation of Standard Operating Procedures (SOPs), Internal Study Protocols (ISPs)/Work Orders (WOs), and reports, and in tracking identified activities relating to clinical study management. Coordinates study development and execution, and the establishment of project timelines and budgets for assigned projects. I also have over 20 years of Quality expertise in Medical Manufacturing throughout a variety of positions. (2 years as a Quality Manager and 7 years as a Quality Supervisor.) When I was a Manager, I planned our production based on historical data of previous production rates and also with Sales and Marketing forecasts. I was a Quality Manager for 2 years at MDMI (Vancouver, Canada), a Sr. Supervisor at Medtronic (Santa Rosa, CA) and a Quality Assurance Inspector at Guidant (Temecula) I work great under pressure and consistently strive to ensure that Roche Internal and External Customer's needs are met in a timely and efficient manner. I work diligently with Planners and GSM, (Global Supply Management) to understand the requirements of everyone's needs. Great understanding of FDA guidelines and Regulations, ensuring that product gets released with all the necessary documentation and SAP transactions completed. Consistently try and find new ways to improve cycle times and reduce non-value added actions with all Teams across the Manufacturing floor to ensure that we remain Lean.

Experience

Clinical Research Coordinator

Ventana Medical Systems, Inc Mar 2007 - Nov 2019

Tucson, AZ (US)

Clinical Sciences Project Coordinator 01DEC2014 to Present (Position is being Phased Out)

• Coordinates assigned projects development and execution, and maintaining project schedules and communication to stakeholders.

• Proactively responds to project schedule delays utilizing knowledge and judgment to determine the best corrective actions to recommend to the project team and management.

• Facilities the preparation and review of deliverables for clinical and lab services projects, and the logistics of a harmonized sample process flow (between CSM, BSM, Histology, and Pathology). Interfaces with laboratory personnel, quality control and the medical and scientific staff; coordinates data reporting.

• Assists in the review and preparation of Standard Operating Procedures (SOPs) and Internal Study Protocols (ISPs); recommends updates and revisions.

• Compiles and summarizes data and generates standard and ad hoc reports as needed. Makes appropriate recommendations to management to improve process efficiency.

• Tracks identified activities relating to clinical study management projects and facilitates communication between various functional groups throughout the organization as required to expedite clinical study execution and project deliverables.

• Participates in Quality Assurance/Quality Control process; reviews for compliance with SOPs and regulations.

• Schedules and attends meetings, takes notes and tracks action items upon request.

Quality Assurance Technician Mar2007 to 01DEC2014

Ensure that all Reagent Teams needs are being met consistently and ensuring that product gets to finished goods in a timely manner, here in Tucson, Hungary and outsourced vendors.

This is accomplished by aligning with the Planner, Team Lead and co-workers to ensure that we consistently meet the needs of our Customers. Cross trained on all Reagent Teams products or processes. Attended MRB to review NCR’s and helped with Investigations. Working knowledge of SAP and Agile.

MDMI

Richmond, BC Canada

Oct 2002 - Aug 2004

Manufacturing Manager

Medical device manufacturing Start-up Company located in Richmond, BC; Canada. We had multiple production lines for different types of products. These product lines consisted of a thermal control unit, and disposable catheter for a thermal endometrial ablation device, a PTCA Catheter product line and a contract manufacturing line. I initiated all of the necessary documentation to transfer the product from R&D into Manufacturing.

I was able to retrieve necessary testing requirements from lab notebooks and initiated the specifications for the endometrial ablation device with very minimal assistance from R&D Engineers. Also worked with various International agencies including CSA, which is the equivalent of Underwriter's Laboratories.

Medtronic

Santa Rosa, Ca

Jul 1995 - Oct 2001

Sr. Manufacturing Supervisor

I worked in the AneuRx division of Medtronic/AVE since June 1999. (I once had 85 direct reports) I was the Supervisor in charge of the Catheter Line. These Catheters are used to treat aneurysms. We had some challenging times due to a recall for improper labeling and process issues. Due to the recall, we had to re-structure our production area and re-validate our systems. We also revised 90% of our Manufacturing process instructions to ensure that we would be capable of passing an FDA audit. By making all the necessary changes, we were able to get our product back out to the market in a timely manner. Once we were up and running, we managed to beat and exceed our production goals for 6 months straight. We were also able to increase our yields by 20%. (When I left, our yield was at 95%)

Stent Supervisor 2

I was responsible for 35 employees in the Stent Electro-Polish / Final Inspection area

I was on an NCMR (Non Conforming Material Report) team that was given the responsibility to reduce the number of NCMR's generated in our department. While on this team, the numbers of NCMR's were reduced by 75%. I also worked closely with the Engineering staff and consider my technical abilities one of my best attributes. I work well with all my co-workers and understand the importance of the systems that are needed when launching product in the US.

(ISO/FDA guidelines)

DVI Guidant

Temecula, Ca

May 1992 - Jun 1995

I performed Inspection methods on Atherectomy Catheters. I also worked with Quality Assurance Engineers and Manufacturing Engineers on the acceptability of the finished product per specifications.

References

Mark Adler

VP R&D Product Development at Canary Medical

cell 858-***-****

Larry Rogers

Independent Private Consultant

cell 650-***-****

Araceli Feliciano

Sr Manager, Clinical Sciences Management

Cell 520-***-****

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