Linda Frazo

*** ********** **

Hamlin, NY *****

Home 585-***-****

adq5w6@r.postjobfree.com

SUMMARY

Highly motivated Pegasus Production Technician with 32 years of experience specializing in the optical, pharmaceutical and medical device industry. Solid technical background with extensive knowledge of processes, machine setup, operation, quality, regulations, policies and procedures. Possess strong leadership and successful teambuilding capabilities. Resourceful troubleshooter with proven ability to bring quick resolution to challenging situations.

EXPERIENCE

Bausch & Lomb, Rochester, NY

Lead Lensmaker/PAQ Operator, 2007 - 2015

Operates a fully automated PAQ line in production and validation mode from casting to packaging of the Purevision line of contact lenses.

•Coordinates and communicates with support departments to assure that the necessary materials, information, and services are available for the line.

•Understands and completes required quality procedures and documentation (ie. Line clearances, CAMS transactions, Lot MO’s, Training Records, and Validation Paperwork)

•Track downtime and yield issues and elevate them to Engineering, PAQ Lead, Quality or maintenance as appropriate

Pegasus Production Technician III 2015 - 2021

Current Ultra Temp Group Leader on A shift Feb 2021 – Present

Selected among many peers to fill a Temporary Group Leader role on A shift.

Learned and participated in Bausch Health’s Gemba Lean Manufacturing Improvements methods.

Successfully initiated a quality event when team member found metal shavings on production line. Appropriate action (Quality group/Maintenance group etc.) was taken and was able to bring a timely resolution minimizing downtime.

Led the team on L2 on a successful protocol evaluating crystal multifocal tooling Iteration #3 and #4.

UCB Pharmaceuticals, Rochester, NY

Process Expert/Capsule Filling, 2002 - 2006

Setup, operate, and manage the entire production process of Metadate CD Extended Release Capsules. Cross trained on the manufacture of different liquid products such as Delsym and Tussionex. Cross trained on coating processes such as Glatt and Wuester coating. Setup and operation of several types of prescription drug packaging equipment.

•Setup and operate required machinery including, capsule filling machine, checkweigher, polisher, metal detector and various weighing devices

•Perform and document appropriate quality checks guaranteeing adequate fill weights specified by designated batch card tolerances

•Uphold First Time Right goals by auditing batch card after manufacturing ensuring that all entries (over 150) have been recorded and calculated correctly by all operators before submitting to QA

•Motivate others in the achievement of individual and organizational goals

•Train coworkers on new procedures and positions as required

•Working with controlled substances and following specific FDA regulations

•Maintaining strict cGMPs as required

•Functioning in a self-directed team environment

Bausch and Lomb, Rochester, NY

Lead Lensmaker, 1991 - 2002

RP-III, Next Generation Cast Molding (Next Gen), Purevision - Operated a fully automated cast mold lens manufacturing line in production and validation mode. Coordinated and communicated with support departments to assure that the necessary materials, information, and services were available for the Next Generation Cast Mold line. Setup and operate DAC horizontal CNC diamond cutting lathes. Setup and operate Sumitomo injection mold machine. Performed a variety of manufacturing duties to include wet lens audit, utility, blister inspection, cosmetic inspection and APL operation per SOP's. Succeeded as a self-directed work team.

•Assisted engineers in the debugging and validation of a new state of the art lens manufacturing process.

•Gained a vast variety of knowledge on the developmental stages of a new process. Participated in several validations and protocols

•Understand and complete required quality procedures and documentation (ie. line clearances, CAMS transactions, Lot MO's, Training Records, Validation paperwork)

•Wrote and edited several new SOP's and GMP's supporting a new process

•Support ISO and FDA requirements and audits

•Troubleshoot the origins of specific cosmetic defects in order to maintain high yields

•Maintained scheduling and workflow of line from start to finished product

EDUCATION

Livonia High School, Livonia, NY

H.S. Diploma, Science, 1988

Monroe Community College, Rochester, NY

Completed classes include College Composition, Technical Documentation, Medical Terminology, Human Biology, and Modern Business

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