This position will lead projects targeted at enhancing the performance of existing ProActive Solutions USA (PAS) products, developing new applications for existing PAS products, and developing new PAS products.
They will also serve as a department expert on materials.
Responsible for FDA, NSF, and EPA regulation adherence. Maintain and make changes for R&D procedures and SSOPs as needed for regulatory adherence.
To be a team player and work by our Company Values : honesty, integrity, ethics, hard work, trustworthy, team oriented, goal oriented, results driven, compassionate, respect of others, customer oriented, employee oriented, an environmentally safe.
ESSENTIAL FUNCTIONS AND ACCOUNTABILITY
1. On a weekly basis for research and development perform digital research, formulations, scale-ups; maintain lab reagent inventory, pick orders, order, reagent closet inventory and other inventory management.
2. Create and maintain design control SOPs, product process and phase management process and new product development process procedures.
3. Understand the environment of use for a new product and customer satisfaction criteria.
4. Execute new product and application research utilizing formal PAS procedures.
5. Define project scope, tasks, and plans; direct activities according to the project plan; develop internal and customer plan to validate the chemical process theories;
and analyze and interpret data.
6. Act as the liaison between the departments and its internal and external customers’ research / scientific staff.
7. Assures raw materials, packaging materials, finished goods and distribution activities meet specifications.
8. Provides technical guidance and works closely with local manufacturing and distribution on major new product introductions.
9. Responsible for FDA reporting CSV file maintenance, reporting listed drugs and biological products, and new product registration / formulation change and product re-registration.
Bi-annual product review with FDA submissions and annual FDA facility registration.
10. May select, train, develop, retain and manage associates according to regulatory standards.
11. Works cooperatively with the Production and Distribution Departments to identify root causes of quality issues and help implement processes to resolve and prevent issues.
12. Generates and implements ideas that improve quality indicators, in line with cost, investment and service goals.
13. Assist with lab budget, technical service requests, purchase order / inventory management.
14. As needed, perform sampling of wastewater tanks for GB Metro Sewer and Badger labs.
15. Works with Purchasing to qualify and rate local vendors of raw materials, packaging materials and finished goods.
Education and Experience :
- Bachelor’s degree in chemistry, chemical engineering, or related discipline
- 5-7 years in chemical manufacturing or R and D
- Experience with regulated (EPA and / or FDA) product manufacturing
- Strong written and oral communication skills and experience with ERP and electronic specification systems
- Expertise in ISO 9001, GMP and in managing quality improvement projects