Job Description
Job Title: Regulatory Affairs Analyst
Job Location: Downers Grove, IL, USA
Job Location Type: Remote
Job Contract Type: Full-time
Job Seniority Level: Mid-Senior level
The Regulatory Affairs Analyst is responsible for coordinating and ensuring all Hearthside finished product specifications are populated, published and filed in an accurate and timely manner per project expectations.
Job Duties : Duties may include, but are not limited to the following: - Reviewing, updating, coordinating, publishing and filing finished product specifications.
- Supporting food safety and quality functions in enterprise wide systems that include but are not limited to: SAP, customer portals, TraceGains software and Product Vision.
- Enter in all raw material data into Product Vision for further ingredient and nutritional work for Regulatory Specialists and Product Developers when needed
- Interacting with customers, suppliers, other functions to obtain, understand information and ensure compliance to regulations, customer requirements and Hearthside Food policies and procedures.
- Quality representative and coordinator of finished product specification publishing, filing.
- Utilizing quality strategy and priority to drive
- Coordinating resources from multiple functions and layers for information into specifications.
- Ability to articulate project impact to organization.
- Support regulatory team with any additional tasks, special projects and back up Regulatory Affairs Analyst and Specialist job duties from time to time
- Follow Good Manufacturing Practices (GMPs) at all times.
- Comply with all safety, health and environmental regulations as prescribed by law.
- Comply with all Company rules, regulations and policies.
- Perform other duties as assigned.
Required Competencies & Knowledge : Knowledge of: - Hearthside procurement, products, and production processes
- Knowledge and experience with SAP, TraceGains, Excel, Powerpoint
Skill in: - Must have excellent oral and written communication skills.
- Strong self-confidence.
- Strong will to drive change.
- Excellent problem solving skills and the ability to work with autonomy.
- Excellent presentation and training skills
- Must be accurate, detail-oriented and maintain the utmost confidentiality.
- Must be detail oriented.
Ability to: - Communicate in English to give and acknowledge instructions/problems.
- Physical and mental ability to work in excess of 40 hours per week.
- Ability to calculate figures.
- Ability to add, subtract, multiply and divide in various units of measure, using whole numbers, common fractions and decimals.
- Ability to define problems, collect data, establish facts and draw valid conclusions.
- Ability to write routine reports and correspondence.
- Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
- Ability to interpret a variety of instructions furnished in written, oral, diagram and/or schedule form.
- Ability to work well with others in stressful situations and meet deadlines as necessary.
- Ability to handle multiple priorities and tasks.
- Excellent keyboarding, record keeping and follow-up skills.
- Ability to work in a fast paced environment, while at the same time making sound decisions.
Proficiency in : MS Office Suite and SAP
Work Environment : - Maintain harmonious working relations with employees from all departments.
- Maintain harmonious working relations with management from all levels.
- Communicate effectively with all employees and management.
Minimum Qualifications :
- 3 – 5 years experience in Data Entry, Technical Product Documentation
- 1 – 3 years experience in Regulatory Affairs, R&D
- Experience with Good Manufacturing Practices (GMPs), Hazard Analysis Critical Control Points
Founded in 2009 and headquartered in Downers Grove, IL we are a world-class contract manufacturer producing wholesome baked goods, snacks and packaged foods for many of the world’s leading food companies. As one of the largest and fastest growing food co-manufacturing companies in the US, we are the proud owner and operator of over 35 facilities globally. Our nearly 10,000 employee-strong organization is leading the way and setting new standards for quality, safety, flexibility and efficiency while feeding families around the globe.
Hearthside’s exceptional growth stems from its ability to address real-world problems for customers of all shapes and sizes, and by our resolute commitment to our belief that there are no great companies without great culture. Our culture of personal empowerment enables growth, learning, and continuous improvement every day!
We are steadfast in our ambition to be the indispensable and most trusted partner to our customers and need your help to do it! Join Hearthside and enjoy a competitive package, outstanding benefits and a diverse work environment.
Hearthside is an Equal Opportunity Employer.
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Job Tags
Full time, Contract work, Remote job,