Erwin Newman

**** **** ***** ****, ******** Meeting, PA 19462

Email: aczrp4@r.postjobfree.com

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

267-***-****

Manny Adair

First Shift Production Supervisor

Pfizer Global Manufacturing

610-***-****

Ben Christman

Lead Operator

Pfizer Global Manufacturing

610-***-****

Jules Quartapella

Glaxo Smith Kline

215-***-****

Tisha Allen

Medimmune

First Shift Supervisor

856-***-****

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