Project Manager Quality Assurance

Profile

Highly motivated professional with exceptional written and interpersonal skills seeking an opportunity within the regulated industry where I contribute and grow within the organization as a regulatory affairs professional.

Education

St. John’s University, New York August 2012 – May 2016

Bachelor of Science in Chemistry, Cum Laude

Work History

Professional Disposables International – Montvale, NJ May, 2016 – Present

Regulatory

Assist in coordinating test requirements and document preparation for Non-GLP and GLP efficacy testing, for new and existing products to substantiate claims

Streamlined the process of organizing testing and improved efficiency and assisted in document retention with R&D Project Manager and formulation chemists.

Critically reviewed EPA submissions to assist the Regulatory Affairs EPA team from a technical standpoint.

Review formulations/ingredients for country/regional compliance.

Researched efficacy requirements and regulations to assist with preparation of regulatory strategy for EPA products.

Reviewed and assisted with preparation of high quality technical documentation for EPA submission.

Ensure that necessary scientific data, studies, documentation, interpretations and information is available to support regulatory filing requirements for assigned products.

Developed and maintained a database of regulated products to track the test requirements and results on alternative product components; which assured regulatory compliance for cost savings projects.

Developed and implemented SOPs to ensure cross functional compliance to revisions of compendial methods and standards.

Actively participate and attend Consumer Specialty Products Association Antimicrobial Products Division meetings to keep current with regulatory requirements

Nice-Pak Products / Professional Disposables International - Orangeburg NY May– August 2015

Quality Systems Document Control Internship

Worked under Quality Assurance on a cross-functional team to validate and expedite the migration of documents from a legacy document management system to MasterControl.

Provided support during an International Council for Harmonisation (ICH) Inspection.

Nice-Pak Products / Professional Disposables International - Montvale NJ May– August 2014

Regulatory Affairs Internship

Created and cross functionally collaborated with Legal, Regulatory, R&D and Marketing to obtain approval for Over-the-Counter (OTC) drug claims.

Worked with R&D to substantiate and support label claims for OTC drug and Cosmetic products.

Researched and trained on drug stability and FDA labeling standards.

Activities & Honors

American Chemical Society Division of Analytical Chemistry May 2016

2016 Undergraduate Award in Analytical Chemistry

Number one ranked undergraduate analytical chemist at St. John’s University

Professional Affiliations

CSPA, Antimicrobial Products Division – Member May 2016 – Present

American Chemical Society – Member January 2012 – Present

Sigma Alpha Pi - National Society of Leadership and Success September 2013 – May 2016

Contact this candidate