Product and process development, qualification, commercialization and business support focusing on OTC drug and EPA regulated wet wipe products. Complete technical assignments, write process and procedures required to qualify new raw materials to deliver the best net value products to market in the shortest time possible, while complying with all safety, environmental and regulatory requirements.
NATURE AND SCOPE
The position will have responsibility for product and process development of new and improved OTC drug and EPA regulated wet wipes. Responsibilities include technically supporting the development of new products and major product improvements from concept through commercialization, as well as ongoing business support for customers. The position will be responsible for working with project teams to ensure consumer acceptance, customer satisfaction, safety and regulatory compliance of Rockline wet wipe products. Associate will work closely with Rockline’s wet wipe manufacturing team to ensure that product design and raw materials are properly qualified and validated to be compatible with process capabilities.
The position is located in Sheboygan, WI. Work hours are flexible, generally from 8:00 – 16:30, Monday through Friday. The associate will have frequent interaction with outside vendors to specify, optimize and qualify raw materials. The position will also support Sales efforts with technical analysis, regulatory interpretation, competitive product evaluations and sample preparation. A high level of initiative and independent work style are expected in order to meet the aggressive timelines demanded by customers.
EDUCATION REQUIRMENTS AND SKILLS
1. B.S. and preferably M.S. degree in a science or engineering discipline from an accredited university.
2. Minimum 5 years experience in OTC/EPA regulated product development or project management function with a proven track record of new product developments. Must have in-depth knowledge of US and Canadian OTC Drug Product and EPA Regulations.
3. Must be willing to travel (~20%). Valid passport and driver license will be required.
4. Working knowledge of cGMP, GLP, safe laboratory and manufacturing practices.
5. Must be self-motivated, mature in attitude and able to work with minimal supervision.
6. Must have excellent written, verbal, interpersonal, quantitative and computer skills.
7. Must be proficient in programs such as Minitab, Office, Outlook, Excel, Word, Project and PowerPoint.
8. Must be able to support complex projects, problem solving and technical challenges impacted by changes in regulations.
9. Must be able to manage multiple projects and tasks concurrently, prioritizing business needs effectively across projects.
a) Develop new OTC Drug and EPA regulated wet wipe product formulations and optimize existing formulations against a development brief and project authorization with guidance from team leader. This will involve liaising with internal departments, external suppliers and regulatory consultants.
b) Provide US and Canadian product related information and regulations for OTC/EPA wet wipe products developed and manufactured by Rockline to internal and external customers.
c) Prepare and maintain Product Information Portfolios (PIP) for each wet wipe product to comply with regulations as required.
d) Support sales team by providing new product development information, timelines and project updates. Travel to specific suppliers and customers when requested, make formal presentations and provide technical information and complete follow-up request as required.
e) Responsible for raw material and product qualifications as required. This includes challenge testing, analytical testing, dermatological testing, stability studies and other technical evaluations etc, within a time scale as necessary.
f) Arrange, manage and technically support product and process trials as required. This will involve liaising with operations, production planning, QA and Stability Testing Coordinator to assure proper qualification and project objectives are met.
g) Investigate and recommend new test methods for analytical evaluation of APIs and other ingredients. Substantiate product performance of a new or existing products or formulations. This will involve liaising with Corporate & Manufacturing QA, external laboratories and consultants.
h) Prepare and maintain raw material and finished product specifications, product development reports, related processes and procedures.
i) Evaluate competitive OTC/EPA products and provide key technical and regulatory knowledge.
Please send your resume to the following email address: firstname.lastname@example.org
Rockline Industries, Inc - 11 months ago
Rockline Industries is a family owned corporation established in 1976.
Rockline is principally engaged in the manufacturing and marketing...