Erwin Newman
**** **** ***** ****, ******** Meeting, PA 19462
Email: *******@*****.***
Home: 610-***-****
Objective:
To obtain a position in the field where I am able to utilize my skills and experience, while increasing knowledge and the level of responsibility.
Skills:
• Accurate, clear and timely communication of information, including verbal, written and listening skills
• Highly dependable, punctual and able to work in a fast-paced environment
• Willing and able to learn and adapt new systems quickly
• Works efficiently and independently with minimal supervision
• Ability to plan and organize giving attention to detail and follow-through
• Reliable judgment that is consistent, adaptable to unusual situations, realistic, common-sense approach to job and problems
• Motivation, initiative, commitment to self-improvement
• Willingness to consider other’s ideas and to work with others
• Knowledge of Windows, Microsoft Office, Internet, LIMS, MODA, MAPS, Oracle, and QDI Lab Equipment Experience:
Role in assay processes, aseptic filtrations, along with exceptional aseptic technique, obtain bubble point of filters and the use of other equipment including:
- Micropipettes - Scales - Peristaltic
pumps
- Mixing tanks - Girton washer
- Mixers
- pH meters
- Agar plates
- Refrigerators
- Biological safety
cabinets
- Met one particles
counters
- Chemical
triblender
- Lyophilizers
- Vacuum pumps
- Gamma
counters
-
Incubators/water
baths
- Freezers
- Soft wall flow
hoods
- Autoclaves
- Disinfectants
- Sporicidal
solutions -
Ultrasonic cleaner
- SIP/CIP
processes
- Bubble point
integrity
tester
Professional Experience:
Fujirebio Diagnostics, Inc.
Fill/Finishing Tech (June 2010 - November 2015)
● Experience in diagnostics/pharmaceutical industry with knowledge of lab equipment.
● Knowledge of GMP’s, SOP’s and batch records.
• Verifies all batch records, SOP’s and specs are up-to-date and reflect the current procedure.
● Temperature logs
● Class 100 gown qualified.
• Performs and documents line clearances before each operation. Performs reconciliations and reports
any discrepancies immediately.
• Prepares filling units, generates labels for accountability boxes, performs balance verifications and issues batch records.
● manually fill vials, such as radiation, human and animal serum using aseptic technique
• Fills, caps and labels products while performing visual inspections in accordance with Device Master Records.
● Perform various types of environmental monitoring
• Provides assistance and training in operations as requested.
• Assures the correct labeling is applied to the product.
● Enters daily production into computer.
● Sterilization of equipment using autoclaves
● • Assures adequate inventory to meet weekly production schedule.
●Mechanically inclined towards related and general machinery
● Disposal of biohazard waste
Medimmune Vaccines
Pharmaceutical Technical Specialist (May 2009 - June 2010)
● Produce FluMist/H1N1 vaccine under cGMP compliance.
● Inspected sprayers for any damage made to the sprayer that may affect the integrity of product
● Environmental Monitoring using SAS and Met One machines
● Log samples into LIMS and MODA.
● Reconciliation of Batch record and Submitting Samples for Testing.
● Training includes:
- Blending of live virus
- CIP/SIP of tanks
- Preparation of parts and tools
- Aseptic technique
- Gowning qualification for grade A and B area
- Water Sampling
- Controlled and non-controlled facility cleaning.
- Filter integrity testing
• Perform in process and documentation review of batch record stage batch record to specific rooms primary or secondary.
• Review all documentation ensuring validity
• Investigate and ensure proper corrective action is identified and taken in compliance with all policies procedures and regulations.
Glaxo SmithKline/Pfizer
Process Operator B (March 2004 - September 2008)
●Worked in critical aseptic environments applying cGMP and SOP compliance to all work activities
● Responsible for daily, weekly, and monthly laboratory maintenance
● Scale and pH meter calibration
● Temperature logs
● General biological safety cabinet upkeep
● Disposal of biohazard waste
● Comprehend technical documents and follow mechanical procedures
● Aseptic gown qualified
● Trained to handle medically significant toxic chemicals
● Prepared tools and equipment components
● performed aseptic and sterile filtrations
● Loaded freeze dryer lyophilizers
● Cleaned class 100 areas using aseptic techniques
● Prepare liquid drug products for filling including calculations for bulking and adjusting products according to set pH ranges
●Monitored and evaluated the ongoing and overall process to ensure the safety, quality and identity
● Entered data into systems using MAPS and maintained inventory levels Norristown Transnet
Route Driver (January 2003 - February 2004)
● Assist in loading and unloading elderly and handicap passengers Aluminum Athletic Equipment
Shipping and Receiving (May 1997 - June 2003)
● Loaded and unloaded trucks, packaged materials, pulled and placed orders
● Prepared equipment using table saw, drills and other power tools Education:
ITT Technical Institute 2012 - 2015
● Associates degree in computer and electronic engineering Plymouth Whitemarsh High School 1993 - 1997
References
Kenny Wells
Fill Tech
Fujirebio Diagnostics
Manny Adair
First Shift Production Supervisor
Pfizer Global Manufacturing
Ben Christman
Lead Operator
Pfizer Global Manufacturing
Jules Quartapella
Glaxo Smith Kline
Tisha Allen
Medimmune
First Shift Supervisor