Alicia Scheidt-Balfe is seeking a full-time, part-time, or contract position utilizing her 6 years of GMP experience in pharmaceutical quality assurance and stability analysis, 7 years of customer service experience, and skills in data entry, technical writing, and administrative tasks. She has worked for BioMarin, Dynavax Technologies, Chiron Corporation, and Good Earth in quality assurance analysis, stability testing, customer service, and technical writing. She has a Bachelor's degree in Molecular and Cell Biology from UC Berkeley and is currently taking an online technical writing class.

1. ALICIA M. SCHEIDT-BALFE
Address: P.O. Box 103, Fairfax, CA 94978-0103
Cell: 415-342-5170
Email: Alicia.Balfe@Gmail.com
Objective
I want to find a full-time, part-time, or contract position in any industry that would utilize my skills that I have listed below. Ideally, I
would like to work in a Quality Assurance position, Administrative position, or a Technical Writing position.
Work Related Skills
Six years of GMP experience working for Pharmaceutical Companies as a Stability and Quality Control Analyst
Worked in Customer Service for seven years
Strong Data Entry abilities
Competent in performing and interpreting various immunodiagnostic assays.
Ability to effectively convey verbal instruction and can demonstrate leadership abilities.
Able to understand technical subject matter and convey or write about it in a manner that a non-technical individual could
understand
High-energy, enthusiastic, dependable individual who excels in challenging, competitive, and fast-paced environments.
Friendly, outgoing, and have excellent interpersonal and analytical thinking skills and abilities
Eager, willing, and able to learn new skills and abilities.
Proficient in the use of both Windows and Mac operating platforms and various applications such as Power Point, Access,
Excel, Microsoft Word, LIMS, and Softmax.
Work Experience
Technical Writer/Clerk 2011-2012
Good Earth - Fairfax, CA
Responsibilities:
Administrative tasks, customer service, cost-out analysis, inventory, technical writing of instructional documents, effectively worked
in a team environment, and conflict resolution.
BioMarin Pharmaceuticals 2007-2009
QC Stability Coordinator II/QC Analyst II
Responsibilities: continued below
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2. ALICIA M. SCHEIDT-BALFE
Address: P.O. Box 103, Fairfax, CA 94978-0103
Cell: 415-342-5170
Email: Alicia.Balfe@Gmail.com
Completed administrative tasks in the QC Analytical Department.
Ensured that our products were placed on Stability per the FDA guidelines in a flawless and maintained hundreds of
electronic records in an electronic database and archived the hard copies of all Stability, Release, and Development Product
paperwork
Created a excel document in GMP program to track and trend all electronic and archived testing records to make them
readily available upon request.
Maintained and ensured that all useful and frequently used documents were up-to-date in revision and ensured that
photocopies of hundreds of documents were on hand for QC laboratory analysts at all times.
Reviewed various GMP documents for errors and for possible revisions
Wrote SOPs for test methods and procedures
Ran the stability department for Kuvan
Distributed daily testing samples
Maintained log books
Created testing packets
Created test result packets that summarized all the results and electronically entered test results and organized the
respective paperwork in a distinct hard cover packet for each lot of each product in the Stability inventory.
Put new lots on Stability per FDA guidelines
Insured all testing was completed within the testing window
Carried out all administrative tasks as required for four different managers at all times
Carried our various immunodiagnostic assays for both our biological and pharmaceutical products.
Dynavax Technologies 2006-2007
QC Associate II
Responsibilities:
Perform analytical testing for in-process, lot release, and stability samples
Run ELISAs, SDS-Page gels, Auszyme, osmolality, absorbance, and endotoxin assays on a routine basis
Coordinate reference materials by writing qualification reports and protocols and by participating in qualification testing
Managed raw material database by tracking raw materials used in new lots of drug product
Perform monthly maintenance and ran verification on QC lab equipment such as the automated ELISA plate washer and
plate reader.
Participated in formulation and fills of drug product
Revised SOPs for clarification and for use in quality control
Assisted in the development of assays for drug product testing
Chiron Corporation
Development Associate II (Biopharmaceuticals Division) (2004-2006)
Responsibilities:
Staged, Monitored, and prepared novel potent compounds, and protein-based compounds for accelerated and real-time
stability studies
VBSE and Isolator Weigh Dispense Procedures for Novel Potent Compounds
Created an inventory system for recording the storage and delivery of stability samples
Worked collaboratively with QA to develop a BPR for GMP weight dispense operations
Database Management of stability data in MS Access, Audits of Data Summaries for IND fillings
Atlas software validation and risk assessment to support load balancing
EH&S safety coordinator
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3. ALICIA M. SCHEIDT-BALFE
Address: P.O. Box 103, Fairfax, CA 94978-0103
Cell: 415-342-5170
Email: Alicia.Balfe@Gmail.com
Chiron Corporation 2003-2005
QC Analyst II (Blood Testing Division) (2003-2005)
Responsibilities:
Tested antigens for QC release and stability
Developed proficiency in ELISA assays, SDS-PAGE electrophoresis, Silver Stain, Coomassie Stain, Western, and Lowry Protein
Assays
Became proficient in using various laboratory equipment such as densitometer, spectrophotometer, and an ELISA plate
reader
Participated in Sera Qualifications and Investigational Studies for PY096 and DRs
Trained new laboratory staff on various immunoassays
Audited various qualification and validation reports
Maintained lab by ordering supplies, preparing reagents, changing stability chamber charts, and by monitoring inventory of
essential lab supplies.
Adecco Technical 2002-2003
Biopharmaceutical Stability Assistant (Temp. Assignment with Chiron Corporation)
Responsibilities:
Created Monthly Testing Schedules for QC labs that assayed stability samples
Delivered daily stability testing samples
Stability data audit and data entry into LIMS
Cleaned and maintained environmental chambers
Took Monthly and Quietly inventory of all Stability samples at all the various temperatures and conditions for the entire
inventory of samples that were on Stability which consisted of thousands of samples
Education
1) Tamalpais Community Education, Kentfield, CA (2012-Present)
On-line Technical Writing Class
2) University of California at Berkeley, Berkeley, CA (1999-2002)
B.A in Molecular and Cell Biology with an Emphasis in Cell Development
3) College of Marin, Kentfield, CA (1996-1999)
Emphasis in Biology 3.9 GPA
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