Great teams start with good chemistry.
WHO WE ARE
We are a company where people matter.
We are family driven.
We are financially strong.
And we are looking for problem-solvers to join our growing team.
We’re searching for a Regulatory Documentation Analyst to work from our Corporate Office in Brookfield, WI within our SQRA department.
The primary purpose of this position is to develop and control documentation and resources in the Product Quality and Compliance Assurance Department in order to assign regulatory and quality related product information to raw materials and Hydrite products, provide regulatory and quality support for Hydrite products as requested by customers, sales and regulatory agencies, and to accomplish short and long term goals identified as critical to success of the company. As the Regulatory Documentation Analyst, primary responsibilities include:
- Provide assistance and direction to the SQRA Product Quality and Compliance Assurance Department regarding regulatory approval of products.
- Oversee the Approved Supplier Program through administration of the qualification process, including, but not limited to the following activities:
- Participating in the qualification process of new Suppliers and new raw materials, contact Suppliers to obtain the necessary qualification documents, and evaluate all new purchased products for quality and suitability of use.
- Facilitating the review and approval of supplier changes, new supplier specifications, and raw material changes through the Replacement-In-Kind Program.
- Administration, maintenance and communication of changes to the Approved Supplier List.
- Coordinating Hydrite’s Inbound Testing Program for Foreign Products per FSMA requirements.
- Administering the Annual Qualification Program for Suppliers of Food Grade Products per FSMA requirements.
- Facilitate the New Product Approval Process through the IRF System from a Regulatory and Quality Assurance perspective.
- Coordinate the distribution of regulatory and technical support provided to Customers.
- Work with Regulatory Team members on special projects as needed.
- Implement continuous improvement in collaboration with Regulatory Team through process evaluation and implementation of corrective actions.
- Uphold Hydrite’s Standard of Excellence through a continuous commitment to maintain quality facilities and provide quality products and services to internal and external customers.
- Perform all duties outlined in relevant SOPs and all other duties to be assigned.
- Provide support to Sales, Customers, Operations, SQRA, QC/QA, TS&D and Purchasing.
- Work with other staff members to maintain workload balances. Provides back-up support as necessary.
- Support effective communication with all Hydrite departments where responsibilities overlap to ensure success of the branch team.
- This position reports to the Regulatory Affairs Manager.
EXPERIENCE AND EDUCATIONAL CRITERIA
- A Bachelor’s degree, preferably in natural science, chemistry, or related field.
- At least 2 years of related work experience in a manufacturing environment.
- Basic computer skills and knowledge of MS Office.
- Must be able to research regulatory issues, including CFR interpretation, and utilize the Internet.
- Must possess strong problem solving and critical thinking skills.
- Must be self-motivated.
- Must have communication and interpersonal skills, along with the ability to read, write, and speak English.
- Must be able to sit and work at a computer for up to 4 hours per day.
At Hydrite, developing our people is the key to our growth and our success. The list below includes other positions that a person who has successfully mastered this role could potentially move into and/or other responsibilities this role could eventually take on:
1. Regulatory Affairs Manager
2. Product Regulatory Manager
3. And many others!
Benefits and perks include three retirement plans (401k, pension and profit sharing), medical/dental/vision/life insurance, paid time off, tuition reimbursement, adoption assistance, legal services insurance, scholarship awards for children of employees, summer picnic, community giving events, free family wellness coaching including nutritionist and fitness coach.
Watch this Why Hydrite video to find out: https://vimeo.com/201673899
WANT TO STAY CONNECTED? FIND US ON SOCIAL MEDIA
- LinkedIn: linkedin.com/company/hydrite-chemical-co-
- Facebook: facebook.com/hydrite
Learn more about Hydrite on our website: www.hydrite.com/careers