Quality Assurance Control

Mary T. Higgins

** ***** ******

Westerly, RI *2891

Home 401-***-****

Cell 401-***-****

************@***.***

SUMMARY

Analytical Chemist/Scientist/Laboratory Analyst with extensive experience

in the Pharmaceutical Field. Highly motivated with strong

analytical/microbiological/wet chemistry background for Active

Pharmaceutical Ingredients and Drug Product. Extremely detail oriented

with high-level data review experience, as well as document preparation

consistent with Good Manufacturing Practices (GMP) requirements and

Standard Operating Procedures (SOPs). Two years of experience as a

Laboratory Support Technician in support of Process and Development

Laboratories. Possess strong communication skills and excellent team

player.

EXPERIENCE

Laboratory Analyst 03/2013 - 08/2013

Atrium Staffing - Contingency Worker at Pfizer

Scientific Laboratory Services- Surveillance/Stability Testing, Pfizer,

Groton, CT

. Collected SOP's, USP Methods, Master Laboratory Records and written

test procedures for testing techniques for the chemical evaluation of

API and finished drug products. Testing techniques included: Water

Content by Karl Fisher, Loss on Drying, Appearance, Volume in

Container, Extractable Volume, pH

. Performed daily calibrations of pH meters and the Karl Fisher Unit.

. Kept accurate records related to testing and calibration activities in

Equipment Use Records, Laboratory Notebooks

. cGMP's Compliant

. Implemented good laboratory practices (SOPs, cGMPs and safety

guidelines).

Associate Scientist 2012 - 2013

Lancaster Laboratories - Contingency Worker at AMGEN

Process Development Central Services Team - Media Prep Laboratory, Amgen,

West Greenwich, RI

. Provide support to the Process Development (PD) Laboratory

. Independently prepare small scale media and buffer solutions, including

recipe formulation, Electronic Laboratory Notebook Documentation (ELN)

and proper filtration into required containers for storage and use.

. Work as part of a team to prepare large scale batches of media and

buffers

. Build applications for different media types and buffer solutions

. Label received Raw Materials per SOP

. Acquire Material Safety Data Sheets (MSDS) using Site Hawk

. Prepare Equipment Use Records (EUR's) in the Media Prep Laboratory

. Perform weekly verifications on all the balances in the Media Prep

Laboratory

. Perform Laboratory maintenance weekly

. Communicate frequently with all PD teams

Laboratory Support Technician II

Cor-Tech - Contingency Worker at AMGEN 2011 - 2012

Process Development - Central Services, Amgen, West Greenwich, RI

. Provide support to the Process Development (PD) Laboratory

. Independently prepare small scale media and buffer solutions, including

recipe formulation, Electronic Laboratory Notebook Documentation (ELN)

and proper filtration into required containers for storage and use.

. Work as part of a team to prepare large batches of media and buffers

. Prepare applications for different media types and buffer solutions

. Wash laboratory glassware

. Autoclave filter applications

. Responsible for updating the Emergency Response Team (ERT) list on a

monthly basis

. Responsible for obtaining instrument and equipment information for

entry onto the

Maximo Loader

. Write work orders in Maximo (AEE's) for Salvage of Equipment

. Prepare documentation for entry into the Document Management System

(DMS)

. Conduct the Chemical and Media inventory

. Label received Raw Materials per SOP

. Perform Laboratory maintenance weekly

. Inventory the acid, base, and flammable storage cabinets as well as

prepare spreadsheets to provide NFPA information for each chemical

. Acquire Material Safety Data Sheets (MSDS) using Site Hawk

. Prepare and update Process Development Central Services Documents

. Prepare Equipment Use Records (EUR's) throughout the PD laboratories

. Perform Laboratory maintenance weekly

. Communicate frequently with other PD teams

Analytical Chemist/Scientist 2001 - 7/2009

Quality Operations, Pfizer, Inc, Groton, CT

. Responsible for Analytical Method Transfer Exercises and Equivalency

Studies for various High Pressure Liquid Chromatography (HPLC) methods

. Conducted Annual System Suitability Failure Reviews and issued reports

. Reviewed production campaigns and prepared Analytical Campaign Summary

Reports

. Active participant on the New Product Pre-Approval Inspection Team

. Member of the Department Safety Committee and Central Safety Committee

. Received a Quality First Award for leading a sub team of the Central

Safety Committee

. Prepared Specific Product Handling Guidelines for known "sensitizer"

compounds

Associate Staff Analyst 1998 - 2001

Quality Operations, Pfizer, Inc, Groton. CT

. Responsible for Analytical Method Transfer Exercises (AMTE); managed off

hour In-Process Control Testing (IPC); conducted laboratory

investigations; performed extensive data review; and entered results into

the Laboratory Information Management System (LIMS)

. Managed work flow of three interns for one summer in support of testing

of a Manufacturing Process Qualification

. Served as a product coordinator for production campaigns

. Conducted Analytical Method Transfer Exercises and validations for

production of new products

. Prepared validation reports and updated operating instructions for Test

Methods prior to campaign start-up

. Responsible for preparation of Test Method Change Notifications

. Provided comprehensive review and input on Test Methods where methods

were developed by research

. Received a Quality First Award for contribution to a successful launch of

a new product

Laboratory Analyst 1977 - 1998

Quality Operations, Pfizer, Inc, Groton, CT

. Developed significant laboratory expertise in compliance testing,

instrumentation, technical writing, Legal Notebook Documentation, and lab

computer applications.

. Performed extensive High Pressure Liquid Chromatography testing and

Turbidimetric Microbiological Assay testing on API and Drug Product.

Other instrumentation includes Inductively Coupled Plasma Absorption

Emission Spectroscopy (ICPAES), and Atomic Absorption Spectroscopy (AAS)

. Acquired strong background in Wet Chemistry testing e.g.; Arsenics, Heavy

Metals, Residue on Ignition, Extraneous Matter, Kjeldahl Distillations.

Other testing includes Loss on Drying, Melting Ranges, Appearance and

Bulk Density

. Developed successful HPLC troubleshooting skills that resulted in

improving analytical test methods and optimizing instrument performance

EDUCATION

COMMUNITY COLLEGE OF RHODE ISLAND, Warwick RI

AAS in Chemical Technology, 1976

Professional Development:

. Atomic Absorption Spectroscopy

. Perkin Elmer High Pressure Liquid Chromatography

. Fundamentals of Organic Chemistry - Three Rivers Community College

. College Algebra - University of Connecticut

. Six-Sigma Method I

. ACS Sponsored Short Course "Quality Assurance/Quality Control in the

Analytical Testing Laboratory"

. MiniTab Software training for Statistical Process Control "SPC" Charting

. Empower Data Acquisition/TurboChrom Client Server Data Acquisition

. LIMS

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