Linda L Glosser

1039 E CR 425 N
GREENWOOD, IN 46412
(812) 841-7862
lg629d66@westpost.net

EDUCATION: Bachelor of Science in Chemistry/MT, December 2007

University of Cincinnati, Cincinnati, Ohio
Graduated Magna Cum Laude with a GPA of 3.6 on a 4.0 scale

Associate of Science in Laboratory Medical Tech., May 2006

Ivy Tech State College, Terre Haute, Indiana
Graduated Summa Cum Laude with a GPA of 4.0 on a 4.0 scale.

Project Engineer/Validation Engineer January 2010 to May 2010

IPS, Indianapolis, Indiana
site personnel to develop, conduct and review automated procedures and work wit
h construction management team and subcontractors to gather / review vendor and
construction documents (test records, shop drawings, as-built drawings, Procurem
ent / PO information, RFIs, submittals), organize (by system) and make available
to the Commissioning and Qualification execution teams.
* Write and Review department SOPs for content and compliance with regulatory re
quirements.
* Analyze data associated with validation protocols.
* Develop and implement test cases, scripts, and procedures.
* Develop and review test plan, traceability matrices, and scenario maps to ensu
re design requirements are met
* Develop and review functional requirements specifications.
* Conduct periodic qualification evaluations to ensure equipment is qualified.
* Develop validation protocols and associated summary reports.
* Conduct design qualification for relevant process equipment and SOPs.
* Gather and review design documents including drawings and specifications, and
make available to the Commissioning and Qualification execution teams
* Assist the Commissioning team by locating and expediting construction / desig
n / vendor documentation needed to support completion of commissioning execution
tasks.
* Assemble system records (Design, Procurement, Vendor, Construction, and Commis
sioning documentation) into Engineering Turn-over Packages (ETOPS) on a By-syst
em basis for turn-over to client end user; both printed and electronic formats.
Technical Writer/Validation Engineer, June 2008 to December 2009
Eli Lilly and Company (DDAO; Device Lab), Indianapolis, Indiana
Work with global and site personnel to develop, conduct and review automated pro
cedures using SmartLab software. This work supports analytical testing for pharm
aceutical manufacturing operations.
* development project.
* Manage multiple projects to provide documented validation of equipment, contro
l systems.
* Write and Review department SOPs for content and compliance with regulatory re
quirements.
* Analyze data associated with validation protocols.
* Calibration and Validation of all instruments including Calibers, pins, Hamble
n Gauge, etc.
* Develop and implement test cases, scripts, and procedures.
* Develop and review test plan, traceability matrices, and scenario maps to ensu
re design requirements are met.
* Develop and review functional requirements specifications.
* Conduct periodic qualification evaluations to ensure equipment is qualified.
* Develop validation protocols and associated summary reports.
* Conduct design qualification for relevant process equipment and SOPs.
* Assess risks involved in processing steps.
* Develop and review validation requirements.
* Work with validation teams to support and monitor efforts.
Ensure facility validation strategies and policies are followed.
* Lead process validation projects.
* Evaluate quality control data, change control requests (CCs) and validation do
cumentation
* Laboratory Information Management System (LIMS) database software. Regulus, Em
power, Visio, Kiosk, Citrix, Lotus Notes, Snag-It, Velquest (Smartlab), Microsof
t Word, Power Point, Excel, GMP experience.
* Strong analytical/problem solving and communication skills
Research Associate, Chemist May 2007 to May 2008
Trex Enterprises, Inc. Kahului, Hawaii
Work with site personnel to develop and characterize silicon based materials via
a number of techniques.
* Anodic etching with HF and ethanol and various surface functionalization techn
iques.
* Preparation of chemical reagents, pH, ultra violet spectroscopy, titration, HP
LC, SEM Imaging, LC/MS.
* Silicon wafer processing and functional characterization binding.
* Develop and approve protocols and procedures including chemistry calculations.
* Develop and update CRF's.
* Maintain stock and inventory of laboratory supplies.
* Maintaining the chemical inventory and maintenance.
Chemist/QA Rep, June 2004 to May 2007
Pfizer Pharmaceuticals, Terre Haute, Indiana
Work with global and site personnel to test, conduct and review analysis for bat
ch release in the Quality Operations Department of Pfizer Pharmaceuticals.
* Participate in investigations and corrective action identification and impleme
ntation process for environmental and critical system excursions, OOS, OOT, and
Exceptions.
* Review the batch and analytical data generated by manufacturing.
* Review various validation and technical documents to comply with regulatory re
quirements.
* Monitor final batch disposition of manufactured products
* Identify gaps and improvement opportunities within the quality system.
* Review and approve SOPs for quality impact and compliance with regulations.
* Perform technical and administrative review of batch and analytical data for a
ccuracy and compliance with procedures.
* Review and approve QC product testing documentation supporting batch release.
* Develop operating procedures for the laboratory.
* Write reports, business correspondence, and procedure manuals
* Laboratory Information Management System (LIMS) database software. Regulus, Ki
osk, Citrix, Trackwise, Lotus Notes, GMP experience.
Microbiologist/Generalist January 2000 to June 2004
Terre Haute MedLab, Terre Haute, Indiana
Work with outside clinics and site personnel to prepare and perform test analysi
s for the Microbiology Department.
* Collected and prepared specimens.
* Perform laboratory procedures, test analyses, verify record and report lab res
ults on all performed tests.
* Set-up all cultures for incubation, plate routine cultures, herpes, AFB, GC/CT
, Vagstreps.
* Stools for Salmonella/Shigellas, Camplyobacter, Yersinia, E.Coli o157:h7, Stre
p screens, Flu A/B screen, RSV, ect.
* VRE screen, Antigen testing, MRSA screening, GC screen, Vaginal Group B Strep
screen,
* Read and record accurate results of gram stains at 100% accuracy, blood cultur
es,
* Document all corrective actions taken when test systems deviated from the esta
blished performance specifications.