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Carolyn (Fioretti) Marcy

QC Analyst, Quality Control Systems

Sr QC Lead | ASQ CPGP | Seeking New Opportunities | Quality Systems | QC/QA Compliance | RA/CMC | Stability Program Mgmt

Greater Boston Area

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Carolyn (Fioretti) Marcy's Email Addresses & Phone Numbers

Carolyn (Fioretti) Marcy's Work Experience

ARIAD Pharmaceuticals, Inc.

QC Analyst, Quality Control Systems

July 2015 to Present


Quality Control Senior Lead / Stability

January 2011 to September 2013


Quality Control Stability Supervisor

April 2007 to December 2010

Carolyn (Fioretti) Marcy's Education

Stonehill College

Bachelor of Science Biology

1976 to 1980

Harvard University Extension School

Individual Graduate Level Courses

QPS Institute

Master Expert Certification Program

2014 to 2014

Carolyn (Fioretti) Marcy's Professional Skills Radar Chart

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Carolyn (Fioretti) Marcy's Estimated Salary Range

About Carolyn (Fioretti) Marcy's Current Company

ARIAD Pharmaceuticals, Inc.

Contract position through ClinLab Staffing

Frequently Asked Questions about Carolyn (Fioretti) Marcy

What company does Carolyn (Fioretti) Marcy work for?

Carolyn (Fioretti) Marcy works for ARIAD Pharmaceuticals, Inc.

What is Carolyn (Fioretti) Marcy's role at ARIAD Pharmaceuticals, Inc.?

Carolyn (Fioretti) Marcy is QC Analyst, Quality Control Systems

What is Carolyn (Fioretti) Marcy's personal email address?

Carolyn (Fioretti) Marcy's personal email address is c****[email protected]

What is Carolyn (Fioretti) Marcy's business email address?

Carolyn (Fioretti) Marcy's business email addresses are not available

What is Carolyn (Fioretti) Marcy's Phone Number?

Carolyn (Fioretti) Marcy's phone (**) *** *** 268

What industry does Carolyn (Fioretti) Marcy work in?

Carolyn (Fioretti) Marcy works in the Biotechnology industry.

About Carolyn (Fioretti) Marcy

📖 Summary

I am a Biotechnology Quality Professional with several years of experience in leadership roles in Quality Control, involving the development, execution, and management of cGMP, ISO, and ICH compliant systems toward release testing, stability monitoring, and regulatory compliance of Biopharmaceutical, Vaccine, Sustained Release, and Combination Drug/Device products, supporting all phases of development from pre-clinical through post-market approval. I am looking forward to combining my recent Quality Systems and Regulatory training with my leadership experience in Quality and GMP, my interest in Regulatory Affairs, my solid writing abilities, and my appreciation for collaboration and teamwork, in a team lead or individual contributor capacity where I can make substantial contributions toward the support and development of Quality Systems, and toward bringing safe and effective new drug products closer to regulatory approval. My skills include:  SOP and Protocol Development  Method Validation and Transfer  Oversight of Contract Testing Labs  Laboratory Investigations  Review of Data and Trends  Continuous Improvement  Stability Program Management  Development of LIMS Static Data  Coordination of Equipment Qualification and PM  CMC/Regulatory Filing Support  FDA and EMEA Audit Support  Customer Focus  Specification Development  Change Control  Deviations and CAPA  Impact and Risk Assessment  Root Cause Analysis  Lean Six Sigma Green Belt QC Analyst, Quality Control Systems @ Contract position through ClinLab Staffing From July 2015 to Present (6 months) Quality Control Senior Lead / Stability @ Project Leader for all aspects of Purified Drug Substance and Final Drug Product stability programs for several major Contract Manufacturing customers, including development of ICH and GMP compliant study protocols, management of study materials, tracking in LIMS, scheduling and coordination of testing, data collection and review, report generation, deviation reconciliation, impact and risk assessment, leading lab investigations, and championing change control. From January 2011 to September 2013 (2 years 9 months) Quality Control Stability Supervisor @ Supervised 1-2 Stability Analysts toward the execution and maintenance of all of the QC Stability programs at the Hopkinton site, consisting of multiple Contract Manufacturing customers and products at various stages of drug development, in accordance with FDA, EMEA, and ICH Guidelines. From April 2007 to December 2010 (3 years 9 months) Quality Control and Stability Specialist IV @ Wrote and executed stability study protocols and stability program SOP’s toward shelf-life determination of BiovaxID, patient-specific vaccines for treatment of follicular non-Hodgkin’s Lymphoma. Managed outside contract testing of final product vaccine and in-process intermediates. Performed hands-on, pre-purchase evaluation of lab equipment toward increased efficiency for QC testing. Refreshed laboratory techniques while assisting with Western Blot and Quantitative ELISA method development. From July 2006 to April 2007 (10 months) Quality Control Stability and Technical Services Specialist IV @ Managed and executed ICH compliant Stability Programs in support of commercial (combination biological drug / device) products, post-approval process change validations / comparability protocols, and new (biological IND) products under development. Assisted with development, draft, and oversight of execution of analytical methods transfer protocols between SBI sites in US and Ireland. From June 2002 to April 2006 (3 years 11 months) Quality Control Stability Manager @ Managed the Stability Program for all Pre-clinical, Clinical, Pre-commercial, and Commercial ProLease® products. Worked closely with Regulatory Affairs and Quality Assurance to ensure that all stability programs were in compliance with ICH Draft Guidelines and with product-specific, agency commitments and submission timelines. Supervised team of 2-3 (1.5 FTE Analytical Testing, 1.5 FTE Clerical/sample/data management). From September 1998 to June 2002 (3 years 10 months) Principal Analyst, Quality Control @ Supervised QC Raw Materials, Lot Release and Stability Testing for several Phase I, II, and III products. Wrote SOP’s for new Analytical Test Methods and drafted Material Specification documents for new ProLease® drug product candidates concurrent with transfer from Formulations Development. Transferred SDS-PAGE methodologies from Protein Analysis Group to QC; re-qualified existing HPLC methodologies. Developed department’s initial SOP for QC Laboratory/OOS Investigations. From September 1996 to September 1998 (2 years 1 month) Senior Research Associate, Protein Analytical Group @ Provided methods development and analytical support (Protein Extractions, SDS-PAGE, HPLC) to Formulations Development group on ProLease® Development projects, and to Quality Control, in support of early phase stability testing. From December 1995 to September 1996 (10 months) Research Associate @ Contract position through Lab Support From June 1995 to September 1995 (4 months) Research Associate @ Contract position through Lab Support From February 1995 to May 1995 (4 months) Research Associate @ Contract position From December 1994 to January 1995 (2 months) QC Analytical Lead @ As the company's first official QC hire was instrumental in the formation of the Quality Control department. Trained and Supervised 3 analysts. Coordinated in-process, release, and stability testing of drug substance and final drug product for a topical wound healing indication. Drafted SOP's and Material Specifications, developed assay criteria. Contributed toward draft review of IND submissions. From April 1992 to December 1994 (2 years 9 months) Sr. Research Associate @ Developed ELISA test kits for quantitation of cytokines, and other small molecules. Coordinated reagent scale-up from benchtop to manufacturing. Developed specifications for Raw Materials. Wrote SOP's for manufacture and QC of reagents. Conducted stability testing on final kit reagents. From April 1991 to April 1992 (1 year 1 month) Sr. Research Associate @ Developed reagents and assay protocols for Immunoassay based clinical diagnostic and blood banking products. Supervised teams of 1-3 Research Assistants. Performed RIA, ELISA, HPLC (for analysis and purification), Open column chromatography, Protein conjugations (iodination, biotinylation), UV-VIS Spectrophotometry, SDS-PAGE, Western Blot. From 1980 to 1990 (10 years) Bachelor of Science, Biology @ Stonehill College From 1976 to 1980 Individual Graduate Level Courses @ Harvard University Extension SchoolMaster Expert Certification Program @ QPS Institute From 2014 to 2014 Masconomet Regional High School Carolyn (Fioretti) Marcy is skilled in: GMP, Validation, FDA, LIMS, HPLC, ELISA, Biotechnology, Assay Development, Stability, UV/Vis, Change Control, Protein Chemistry, Vaccines, GLP, Medical Devices

Carolyn (Fioretti) Marcy’s Personal Email Address, Business Email, and Phone Number

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In a nutshell

Carolyn (Fioretti) Marcy's Personality Type

Introversion (I), Sensing (S), Thinking (T), Perceiving (P)

Average Tenure

2 year(s), 4 month(s)

Carolyn (Fioretti) Marcy's Willingness to Change Jobs



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