Regulatory Affairs and Quality Systems Specialist - Ascent Industries : Job Details

POSITION DESCRIPTION

Job Title: Regulatory Affairs and Quality Systems Specialist

Reporting: Continuous Improvement Leader

Date: July 2024

Duties and Responsibilities:

* Ensure regulatory compliance and maintain high-quality standards across multiple sites.

* Stay abreast of relevant regulations, guidelines, and standards applicable to specialty chemicals.

* Monitor and review new and existing laws, regulations, and guidelines relevant to our products.

* Analyze the impact of regulatory changes on our operations and products.

* Interpret and communicate regulatory requirements to internal stakeholders.

* Conduct regulatory assessments for new products and changes to existing products.

* Provide regulatory guidance and support to resolve compliance issues and inquiries.

* Work closely with R&D, Production, Supply Chain, and Sales teams to ensure regulatory compliance and quality standards are met throughout the product lifecycle.

* Prepare regulatory requirements and updates for entry into the site ERP system.

* Develop training materials on regulatory and quality topics for employees.

* Prepare and/or update regulatory affair supplier questionnaires for produced materials as requested for new and existing customers.

* Develop, maintain, and update accurate SDS for our product portfolio.

* Distribute new and updated SDS's to internal and external customers as required

* Ensure SDS compliance with global regulatory requirements (e.g., OSHA, REACH, GHS).

* Assist in the implementation, maintenance, and improvement of the Quality Management System.

* Conduct internal audits and support external audits related to regulatory compliance, quality assurance, and ISO9001 compliance.

* Be the process expert and owner of the company's QMS software and associated processes.

* Maintain accurate documentation related to regulatory compliance and quality assurance activities.

* Other duties as directed by the management.

Skills, Qualifications, Experience, Special Physical Requirements:

* Bachelor's degree in chemistry, Chemical Engineering, Regulatory Affairs, or a related field (advanced degree preferred).

* Proven experience (3+ years) in regulatory affairs and quality assurance within the specialty chemicals industry.

* Strong knowledge of global regulations and standards (e.g., REACH, OSHA, GHS).

* Experience creating SDS and familiarity with SDS authoring software.

* In depth knowledge of ISO9001 compliance related to specialty chemicals

* Strong computer skills and experience with a QMS software system

* Excellent analytical skills and attention to detail.

* Effective communication and interpersonal skills to collaborate across departments and with regulatory agencies.

* Ability to prioritize tasks, manage multiple projects simultaneously, and meet deadlines.