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Technician Quality, Supervisor

Location:
Boston, Massachusetts, United States
Posted:
January 11, 2017

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Erik Branch

acx73b@r.postjobfree.com

*** ********** ****** ***. *

Brighton, MA 02135

(617) ***-****

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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