R E S U M E

Julie Baxter

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

Moorpark, Ca. 93021

acz89k@r.postjobfree.com

Cell: 818-***-****

Objective

My aspiration for career path today is planning, scheduling, management, accounting, supply chain or quality assurance. I believe my 11 yrs. of manufacturing experience will be useful in achieving my career goals. I am seeking an employer who values an individual’s unique and creative perspective on company business and seeks out the individual’s unique perspective to be heard.

Experience

2005-2017 Amgen, Inc.

One Amgen Center Drive

Thousand Oaks, California 91320

Position: Manufacturing Associate

DUTIES:

Aseptic removal of liquid drug substance within a LAF hood

Author GMP documents

Buffer prep

Batch record review

Filling of Drug Products

Formulation of Buffers, Placebos, Media, API

Training inexperienced staff in Formulation

Inspection of drug product and packaging labels

Lab analyst testing experience

1.Bacterial Endotoxin

2.Osmolality

3.pH/Conductivity

4.Sub Visible Particles

5.Turbidity

Solid Dosage Bottling Experience

1.Set Up equipment and line operation

2.Manual Filling of small molecules

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Julie M. Baxter

Experience Cont’d.

Certifications

Inspection certified for Amgen products

Inspection certified Amgen packaging/labels

Gowning Certified Level 5 and 7

6 Sigma Yellow Belt Training

Respirator (P95) certified

2007-2008 Cardinal Health (tour of duty and temporary relocation for Amgen, Inc.)

San Diego, CA

Duties:

Fill operations for Vectibix

Formulation for Vectibix

Inspection for Vectibix

General equipment preparation

Sanitization of class 5 and 6 areas as needed

Software Experience

Word, Excel, Power Point, MES

Visio, Citrix, SAP, Enterprise Document

EQUIPMENT /

PROCESS

Assembly and pressurization of stainless steel pressure vessels

Bottling Line Equipment:

Bottle Unscrambler, Cottoner,

Inline Capper, Induction Cap Sealer and Cap Re-torquer

Cozzoli Syringe Filler

Environmental Monitoring:

Climet cl-500, R2S

HACH AN 2100

HIAC / SUB VIS

Mettler Balance Models PM460/XS403S

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Julie M. Baxter

EQUIPMENT /

PROCESS cont’d

Osmometer Model 3250

Personnel and Surface Sampling

PH/conductivity meter in process testing for formulation and fill

PTS LAL testing

Sartocheck III & IV automatic bubble point filter testing machine

Stopper Placement Unit (SPU)

TL System Filler (Model #FSM-2700C) TL

Tray Vial loader (3cc-10cc)

Watson-Marlow peristaltic pumps

West capper Machine Model #RW-600SS with Seal Force Monitor

Troubleshoot clinical manufacturing processes

Coordination of lab supply ordering

Nonconformance (Class I) initiator experience

Provide process theory and hands-on training for

Formulation and Inspection

EDUCATION

2002-2005

Bachelor of Science Degree in Biology California State University

Camarillo, CA

2000-2002

Associates Degree in Liberal Arts

Moorpark Community College

Moorpark, CA

1997

Recording Engineer Degree

Conservatory of Recording Arts and Sciences

Phoenix, Az.

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