My experience to date has been centered in the pharmaceutical industry where I have taken on the roles of Compliance Specialist, Associate Scientist II, Stability Coordinator, and Method Development and Validation Chemist. My day to day tasks have included oversight of a Quality document management system, conducting training, contributing to regulatory submissions, assisting with laboratory investigations, and
My experience to date has been centered in the pharmaceutical industry where I have taken on the roles of Compliance Specialist, Associate Scientist II, Stability Coordinator, and Method Development and Validation Chemist. My day to day tasks have included oversight of a Quality document management system, conducting training, contributing to regulatory submissions, assisting with laboratory investigations, and managing a stability program. Additionally, I have authored several reports, protocols, SOPs, and test methods, developed and validated test methods, and released numerous clinical samples. I believe that my pharmaceutical industry experience, writing skills, organizational expertise, and team work capabilities have contributed to a successful career thus far and I hope to continue to advance and improve upon my knowledge and proficiency.
I recently completed my certification in Regulatory and Quality Compliance. I believe my studies will provide insight and perspective in the quality arena and I hope to apply the knowledge that I've gained to my career going forward.
Specialties: Strong writing skills, enjoy working in a team environment, very organized, excellent problem solver, understanding of cGMP.
Manager, CMC Development and Regulatory @ From February 2014 to Present (1 year 11 months) Quality Assurance Manager @ From January 2014 to February 2014 (2 months) Quality Assurance Associate @ Configured, qualified, and implemented electronic document management system
Oversight of electronic document management system
Authored change controls
Project manager for analytical method transfers
Stabilty data entry and trending
Led company wide training on document management system From April 2012 to January 2014 (1 year 10 months) Compliance Specialist @ Prepared ANDA submissions in eCTD format.
Prepared regulatory documentation in support of ANDA submissions.
Responsible for QA review of technical documents.
Completed comprehensive investigations at client site encompassing laboratory, manufacturing, and packaging departments.
Performed extensive review of documents and conducted numerous interviews with site personnel to identify probable/root causes for events. From April 2011 to April 2012 (1 year 1 month) Associate Scientist II @ Assisted with IND submissions.
Authored several Analytical Research Methods, Test Methods, Scientific Validation Reports, Validation Change Controls, Reference Standard Characterization Reports, and Exception Reports.
Thorough daily adherence to cGMP requirements.
Assisted with laboratory investigations to determine root cause for aberrant and out of specification results.
Determined corrective and preventative actions for nonconformities.
Participated on Knowledge Management teams that furthered the efficiency of the department through generation of standardized report templates.
Assisted in the creation of an electronic database for tracking and locating laboratory equipment.
Developed and validated: assay, related substances, dissolution, volatile impurities, moisture and physical examinations for drug products according to USP, EP, FDA and ICH guidelines.
Extensive analytical instrumentation experience with: HPLC, GC, Volumetric and Coulometric Titrators, Automated Dissolution apparatuses, and unique detectors such as Evaporative Light Scattering and Diode Array.
Proficient with Global Laboratory Information Management Systems.
Received Certificate of Excellence for capsule development and clinical supplies.
Nominated for Global Pharmaceutical Analytical Sciences Teamwork Award.
Member of the American Chemical Society. From February 2008 to April 2011 (3 years 3 months) Stability Coordinator @ Authored stability section of Marketing Authorization Application.
Created over 50 annual stability reports for customers throughout the U.S. and Europe.
Corresponded with clients throughout the U.S. and Europe on a routine basis.
Responsible for oversight of an ICH compliant stability program.
Responsible for all stability sample pulls.
Determined shelf life for over 20 different products.
Updated and reviewed files on stability database.
Performed HPLC and wet chemistry stability testing. From April 2006 to February 2008 (1 year 11 months) Analytical Chemist @ Authored several method development protocols, validation protocols, method development reports, validation reports, memos, reference standard reports, and SOPs for clients throughout the U.S. and Europe.
Acted as lead analytical chemist on early phase finished API project.
Developed and validated assay, purity, and stability indicating HPLC methods for raw materials, intermediates, and finished APIs according to ICH guidelines.
Developed and validated extremely sensitive cleaning verification methods.
Developed and validated volatile impurities methods. From April 2004 to 2008 (4 years)
Certification, Regulatory and Quality Compliance @ Purdue University From 2010 to 2010 B.S., Chemistry @ Illinois State University From 1999 to 2003 Colleen Westerman is skilled in: GMP, CAPA, Pharmaceutical Industry, Validation, Sop, LIMS, Analytical Chemistry, FDA, HPLC, USP, Chromatography, Quality Assurance, Change Control, Document Management, Gas Chromatography
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