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Assistant Director Quality Assurance

Location:
Dublin, OH
Salary:
90000
Posted:
February 17, 2024

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Resume:

*** ***** **

DUBLIN, OH *****

ad3pix@r.postjobfree.com

614-***-****

LinkedIn:

https://www.linkedin.com/in/kristen-koslow1b019110/ Proficient in regulatory compliance, quality standards and best practices. Analytical and detail-oriented professional focused on meeting all relevant domestic and international regulatory requirements. Methodical and objective with good judgment and sound critical thinking and problem-solving abilities. Skilled at preparing and submitting compliance documentation, including reviewing materials, technical data and accuracy of corporate, state and federal required reporting. Articulate and personable with exceptional data analysis, report writing and recordkeeping abilities. Well- organized and a diligent Regulatory and Quality Affairs Specialist adept at coordinating and tracking related actions in the compliance area. Highly successful at keeping on top of changes in requirements to maintain flawless compliance. Offering 21 years' experience in regulatory, quality assurance compliance and looking for a challenging new role. Excellent reputation for resolving problems and improving customer satisfaction. Enthusiastic and eager to contribute to team success through hard work, attention to detail and excellent organizational skills. Clear understanding of compliance; regulatory, quality and social responsibility in the retail industry. Motivated to continue to learn, grow and excel in the compliance field. Professional Experience

Product Compliance Manager Gel Blaster, Inc. August 2022 - February 2024 Developed and implemented comprehensive product compliance policies, procedures, and standards to ensure regulatory compliance and adherence to industry requirements.

Conducted regular product compliance audits and inspections to identify any potential non-compliance issues and implemented corrective actions to mitigate risks.

Successfully managed and delivered multiple complex projects, ensuring that all deliverables were met within scope, budget, and timeline Led cross-functional teams, providing clear communication, direction, and support to ensure collaboration and alignment towards project goals Developed and implemented project plans, including defining objectives, milestones, and resource allocation, resulting in efficient and effective project execution

Conducted risk assessments, identified potential issues, and implemented proactive strategies to mitigate risks and ensure project success Tracked and monitored project progress, provided regular status updates to stakeholders, and facilitated effective change management processes to adapt to evolving project needs

Corporate Compliance Manager Lake Shore Cryotronics February 2021 - April 2022 Developed and managed the company Chemical Compliance program to safeguard products satisfy United States and European Union, REACH, RoHS and EEC requirements.

Created from scratch a SharePoint Site for Company Compliance to enable ease for employees of having Regulatory, Export, Ethics and training at their fingertips.

Responsible for all aspects of Export Compliance including, licensing, product classification with the Bureau of Industry and Security and Harmonized Tariff Classification for shipping according to the U.S. International Trade Commission. Researched potential Clients to guarantee company was meeting the framework set up to comply with effective export control and treaty compliance systems set up by U.S. Department of Commerce. Reviewed Third-party and Non-Disclosure contact providing changes when necessary. Senior Regulatory Analyst ASCENA RETAIL GROUP INC February 2013 - January 2021 Developed and managed Risk Assessment Process for the development of products to ensure regulatory and quality compliance. Worked closely with all product development departments to create and maintain regulatory and quality compliant product. Created and implemented testing, quality and labeling procedures manuals to guarantee compliance with federal, state and international requirements.

Adapted testing guidelines to specific new product lines based on competitors, third party lab and professional retail organizations research. Managed Third Party Testing Program relationship including program processes, protocol development and price negotiation Prepared research and groundwork for Social Responsibility Program including Chemical Management Program, working with Mills, Dye Houses and Factories

Researched, documented and resolved regulatory and quality failures which led to saving product to allow for sale of compliant product. Analyzed benchmarking reports, compiled information and submitted concise and informative summaries and applied updates in programs as warranted.

Prepared and submitted regulatory file applications and supporting documentation. Completed and reported on compliance impact assessments. Received, researched and resolved consumer inquiries. Collected and reviewed data to assess regulatory, quality and social compliance to ensure corporate, federal and state requirements are met. Regulatory Coordinator/Regulatory Analyst Tween Brands, Inc.-Brands: Limited Too, Justice, Mishmash, Brothers February 2000 - February 2013

Reviewed Consumer Product Safety laws and updated company procedure strategies to reflect current information. Subject Matter Expert for tailoring PLC database for Regulatory and Quality Assurance use. Managed quality programs to reduce overdue compliance activities. Created and managed consumer recall processes to meet government agency requirements. Resolved product issue through consumer testing.

Confirmed data and licensing information through investigations and notified violators of required changes to bring operations into compliance. Maintained composure in stressful situations, including confrontations, interviews and records searches. Performed scheduled and unannounced investigations of workplaces to check social and quality conformance. Advised clients on compliance fraud and investigations, as well as potential remedies and required actions. Education

Bachelors of Science Ohio State University, Columbus, Ohio September 1988 - June 1993 Key Skills

Quality Assurance Inspection

Product Testing Evaluation

Product Information Management

Database Management

Data Analytics

Training

Microsoft 365

SharePoint

Product Lifecycle Management Systems

Adobe Creative Cloud

ClickUp Project Planning Software

NetSuite

Accomplishments

-ASTM Committee Member-Toys and Emerging Hazards

-ASTM Work Group-Hydrogel Based Launchers

-ICPSO Member

-Gel Blaster Product Testing Manual

-Gel Blaster Product Labeling Guidelines

- Ascena Retail Group Vendor Quality Assurance/Regulatory Compliance Manual

-Justice Vendor Sleepwear Regulatory Manual & Training

-Justice Drawstring Guidelines & Training

-Justice/Brother's CPSIA Reasonable Testing Program

-Product Recall Policy

-Access Database used for Quality hold process to secure failed products

-Restricted Substance List-Vendor and Manufacture

-Quality Inspection Guidelines

- CAPA and Destruction Programs

-SharePoint Site for internal policy and procedure repository



Contact this candidate