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SHERYL GUERARD

Conyers, GA - 770-285-4952 - hugger883@att.net


Results-driven and detail-oriented professional with a tested and proven track record in quality
control/quality assurance coupled with a keen ability to achieve efficient lab operations. Well versed in
quality principles, compliance gap resolution, and FDA requirements. Respected expert in my field offering
dynamic leadership and problem solving skills along with in-depth GMP and GLP expertise. Valued
contributor to the start up of a new facility. Goal-achieving in introducing new processes and systems that
enhance productivity. Steadily progressing in conflict resolution and promoting teamwork to increase
morale. Available for travel.
CORE COMPETENCIES
Quality Control / Quality Assurance - SOP Review & Development - Quality Systems - GMP Data Review
LIMS - Quality Compliance Management - Bioassay/ELISA - GLP / GMP - Project Management
Facility Start-up - Quality System Documentation - GMP Investigations - Laboratory Operations-Training Process Development
EXPERIENCE
BAXALTA/SHIRE, Social Circle, GA
QUALITY ASSURANCE/QUALITY CONTROL LEAD

Maximized efficiency of administrative processes by completing documentation in a timely manner and


ensured proper filing methods.
Designed and implemented a 4-phase On-the-Job training process that standardized training and
increased efficiency by 75%.
Implemented safety policies that reduced and eliminated incidents.
Managed a team of 100 people and increased performance by following compliance guidelines.
Provided on-going leadership, trained and motivated to complete assignments ensure a high team
performance.
Performed weekly audits to assess compliance gaps.
Worked with Georgia Quick Start to implement training procedures to insure an efficient transition of
new team members into the Quality Control/Quality Assurance Laboratories.
Introduced a new site wide on-boarding process that realized a 95% efficiency in helping new team
members adapt into their group.

ALEXION PHARMACEUTICALS, Smithfield, RI


QUALITY ASSURANCE/QUALITY CONTROL ANALYST III

Mar 2014 Sep 2016

Apr 2012 Mar 2014

Developed, standardized, and evaluated procedures and techniques for tests used in the analysis of Final
product.
Designed and established a working bioassay laboratory for commissioning runs.
Supervised team member s, prepared schedules, trained and assigned specific duties for the bioassay
laboratory.
Worked with outside vendors to set-up accounts that increased laboratory efficiency.
Validated and transferred new analytical methods for new products in the pipeline.
Determined that the high invalid rate for a test method was cause by a chemical used in a buffer. Upon
correcting the buffer preparation the invalid rate was reduced by 90%.

EXPERIENCE
SHIRE HGT, Lexington, MA
SENIOR QUALITY ASSURANCE/ QUALITY CONTROL ANALYST I

Supervised laboratory personnel to assure proper execution of analytical procedures.


Utilized computer software, LIMs and Minitab, to monitor and trend data or Out-of-Specification (OOS).
Launched a new storage system that consolidated samples, helped meet turnaround times, and increased
performance by 30%.
Generated quality system documents including deviations, change controls and OOS through the use of
TrackWise
Facilitated method transfers and validations for analytical methods for new products in the pipeline.

BRISTOL-MYERS SQUIBB, CO., Devens, MA


QUALITY ASSURANCE/QUALITY CONTROL TECHNICAL LEAD

Apr 2006-May 2008

Respected expert in my field for Elisa method transfer and development.


Performed data review and approval for Microbiology, Raw Materials, and Biological assays, reports and
protocols.
Presented safety training to team members to reduce all environmental accidents.
Interacted with the customer to guarantee information sharing.

RENAMED BIOLOGICS, Lincoln, RI


QUALITY ASSURANCE/QUALITY CONTROL IV

May 2008-Jun 2010

Supervised, trained and coached team members to reach their potential.


Played a key role in the successful start-up of the facility by procuring laboratory equipment.
Assisted with bioassay validation that resulted in submission of mission-critical data to the FDA.
Mapped procedures from paper-based to a computer-based system using SmartLab.
Developed and implemented systems for removing and storing hazardous waste materials to eliminate
incidence reporting.
Reviewed vendor documentation for the instrument IQ, OQ and PQs in a timely manner.
Wrote, reviewed and approved SOPs, protocols, verification reports, and transfer/validation reports to
guarantee high tem performance.
Spearheaded the creation of curricula for chemical handling, TrackWise (OOS & OOT), Invalid assays,
control charting, and Job Hazard assessments.

LONZA-HOPKINTON, INC, Hopkinton, MA


QUALITY ASSURANCE/QUALITY CONTROL IV

Jun 2010-Apr 2012

Oct 2005-Apr 2006

Supervised, trained and coached team members in the Immunoassay Laboratory.


Executed the IQ, OQ and PQ for the WQCL to perform endotoxin testing of the facility.
Chaired cGMP information sharing sessions to keep team members in compliance.
Conducted review of data, reports and inspection of materials.

EXPERIENCE

AMGEN INC., QUAL-PHARMACEUTICS DEPARTMENT, West Greenwich, RI & Thousand Oaks CA.
Jul 1999- Oct 2005
QUALITY ASSURANCE/ QUALITY ASSOCIATE III

Oversaw trending of data using excel and other charting software.


Mentored team members in Immunoassay and Bioassay groups.
Chaired cGMP information sessions to ensure compliance within group.
Executed internal audits to assess compliance gaps.
Conducted review of data, reports and LIMs.

EDUCATION
B.S., MICROBIOLOGY - UNIVERSITY OF MAINE AT ORONO, Orono, ME
INTELLECTUAL PROPERTY

Wallach, Tabibi, Mathur, Henderson, Lipid vesicles having an alkyd as a wall material.
Henderson, Wallach, Mathur, Gas and oxygen carrying lipid vesicles

PUBLICATIONS

Donaldson, D, Whitters, M, Fitz, L, Neben, T, Finnerty, H., Henderson, S., Et al. 1998. The Murine IL-13
Receptor alpha2: Molecular Cloning, Characterization and Comparison with Murine IL-13 Receptor
alpha1. The Journal of Immunology, 161: 2317-2324
OHara, R., Henderson, S., and Nagelin, A. 1996. Prevention of a Th1 Disease by a Th1 Cytokine: IL-12 and
Diabetes in NOD Mice. Annals of the New York Academy of Sciences, 795: 241-249
Tabibi, Wallach, Mathur, Henderson Proceed. Intern. Symp. Control Rel. Bioact. Mater., 18 (1991)
Novasome vesicles in extended action pesticide formulation.

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