Technician Quality, Supervisor
Resume:
Erik Branch
***********@*****.***
Brighton, MA 02135
Objective: I am a quality minded cGMP supervisory level candidate looking for a position in a regulated industry that focuses on quality and compliance to FDA and ISO regulations. Experience:
Bunker Hill Community College
Associates in Business Management
Graduation: December 2016
Allergan Medical
2012-2015
Production Supervisor
Supervised 1st, 2nd, and 3rd shift production technicians in a FDA regulated medical device company from start up to shipment of finished goods
Ensured adherence and implementation of structured production plan
Implemented 5S activities and Kaizan Events
Created and amended SOPs, EOPs, QSPs, MOPs, and MBRs
Interviewed, hired, trained, and coached new and existing manufacturing technicians on procedures and policies
Performed monthly and annual reviews of technicians
Root cause analysis for deviations, quality holds, NCMRs, and CAPAs
Implemented and reported KPIs, standard work sheets, and monthly metrics to production management and team
Active participant in cross-function groups to facilitate business needs (R&D, QC, QA, Engineering, Quality Operations, and Manufacturing)
Ensured compliance to all EHS policies and procedures
Batch record review and sign off for completion and accuracy
Participated in all IQ/OQ, Engineering, and PV runs to completion for the transfer of production to Westport, Ireland
Adecco Staffing/Allergan Medical
2010-2012
Lead Manufacturing Technician
Performed and led all manufacturing tasks from start up to shipment of finished goods
Spearheaded continuous improvement of process with engineering
Determined shift work and placement of technicians throughout the process Lighthouse Placement Services LLC/Shire Human Genetics Therapies 2005-2010
Cell Culture Manufacturing Technician
Performed biological growth and aseptic processes while maintaining constant sterilization for the production of commercial and clinical products
Aseptic cell expansions and operation of twin 500L Bioreactors
Performed CIP, SIP, pressure holds, cell counts, cell inoculations, column operations, clarification of harvest material, revising documents, and initiating and closing deviations and quality holds Star Personnel/Brady’s Inc.
2005
QC Technician
Performed all quality control testing on in-process and finished goods
Maintained proper labeling of all finished product
Ensured the proper adherence to all FDA policies and requirements ELAB of Tennessee
2001-2004
Extraction Lab Technician
Performed all extraction processes for environmental waste water/soil testing for PCBs, Pesticides, Herbecides, and Explosives
Performed wet chemistry testing for waste water/soil testing for BOD, TSS, TOS, Flourides, and
% Moisture
Acknowledgements: Award for Operational Excellence 2012, 2013, 2014
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