Michael F. Gustafson

** ****** ****** ac28x8@r.postjobfree.com

Oxford, MA 01540 (Cell): 508-***-****

Summary

A highly reliable, conscientious, and adaptable technician, who is extremely comfortable working in settings where quality, integrity, consistency and the adherence to standard operating procedures are of the utmost importance to ensure the safety of the product and the expectations of the people we serve are never compromised.

Skills and Qualifications

Calibration of Instrumentation and Equipment

Quality Control

Pharmaceutical, Medical and Environmental Settings

SAP Microsoft Office firstDocs Infor LIMS

Standard Operating Procedures

Customer Service and Collaboration

Scheduling and Planning

Laboratory Assays

Experience

Alexion Pharmaceuticals, Smithfield, RI October 2013-Current

Instrumentation Technician II

Perform calibration of all Manufacturing and Quality Control equipment following cGMP to include:

oBioreactors, Chromatography Skids, UF Skids, and Autoclaves

oConductivity, pH, Humidity and CO2 sensors

oPressure, Speed, Temperature, and level transmitters/indicators

oIncubators, Refrigerators, Freezers and Chart Recorders

oUV, Spectrophotometers, and Osmometers

oGas and liquid flow meters

oMass Flow Controllers

oPressure and Temperature Switches

oBalances and Scales

oSartorius and Millipore Integrity Testers

Write and revise Standard Operating Procedures

Capture data using CMMS software (INFOR)

Member of the Safety Committee

Produce and maintain calibration schedule and communicate with planners and department personnel to ensure timely completion of calibration duties and to meet deadlines.

Lonza Biologics via Aerotek, Hopkinton, MA May 2013-Septmber 2013

Preventative Maintenance Coordinator

Coordinate the Preventative and Demand maintenance of all production equipment using SAP software system

Check daily notifications of requested maintenance and assign priority as needed

Forward PM and Demand notifications to appropriate department leadership

Issue spare parts and maintain accurate inventory levels

Review Work Orders for adherence to SOP’s and GMP documentation

File and retrieve Work Orders as needed for audits or as required to close deviations

Review Standard Operating Procedures

Ameridose, Westborough, MA November 2011 –November 2012

Quality Assurance Equipment Subject Matter Expert

Coordinated the calibration, maintenance and repair of over 1500 pieces of equipment

Acted as liaison with Operations to order any necessary equipment

Maintained calibration and maintenance database

Validated new, moved or repaired equipment as required

Wrote deviations of Standard Operating Procedures

Reviewed calibration certificates

Accomplishments

Overhauled entire equipment calibration and maintenance tracking database and system

Introduced new procedure for tracking and maintaining equipment

Audited entire collection of equipment calibration records to ensure conformance to procedures

Instilled the importance of procedures and equipment records for current and new employees

Participated in audits by Regulatory Agencies

Quality Control Laboratory Technician November 2010 – November 2011

Environmental monitoring of clean rooms utilizing:

oSurface and personnel sampling

oViable and non-viable air sampling

Performed Gram Staining

Performed plate counts of bacterial growth

Experienced in using Anprolene Gas Sterilizers

Performed direct inoculation sterility testing using proper aseptic techniques

Growth promotion of incoming media to ensure effectiveness

Monitored temperature of all equipment and facilities

Trained new employees

Assisted in Stability testing of products

Wrote and revised the standard operating procedures as required

Performed Equipment Validations

Executed Raw Material Identity Testing utilizing the following methods:

oOsmolity

oUV-Vis spectrophotometry

oPhysical and wet chemistry

oMelting Point

opH Testing

oEndotoxin testing using the gel clot method

UMASS Memorial Healthcare Blood Bank, Worcester, MA September 2005 –October 2010 Laboratory Support Technician II

Performed calibration of Scales, Thermometers, Platelet Rotators and Irradiator Timers

Manufactured donated blood products into packed red blood cells and plasma

Performed Verax PGD bacterial testing on platelets

Performed Blood typing red blood cell units

Performed moderate complexity testing as designated by CLIA

Performed Physical reconciliation of all blood product inventory

Tested platelet inventory for glucose and Ph

Adhered to current Good Manufacturing practices and Standard Operating Procedures

Wrote and revised SOP’s

Communicated with hospital personnel regarding patient care needs

Logged specimens received from all areas of the hospital

Accomplishments

Played a large role in validating the in hospital blood transportation system

Validated blood storage equipment

Participated in audits by the Food and Drug administration and AABB

Alpha Analytical Labs, Westborough, MA April 2005 –Jan 2011

Organist Prep Chemist

Prepared soils and liquids for analysis

Maintained daily logbooks to track all sample preparation procedures

Centrifuged samples when necessary

Calibrated scales for accurate sample weighing

Calibrated Pippettes

Education

BS Natural Science (Emphasis on Biology and Chemistry) Worcester State College, Worcester, MA

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