Compounding Solutions LLC is a leading manufacturer of custom medical polymer compounds, color concentrate, and additive concentrates for extrusion and injection molding for use in Class I, II, and III medical devices. Our growing business needs a Regulatory Affairs Intern to help aid us in compliance issues, both for domestic and international activities. The position will be working across multiple departments including Quality Control, Logistics, and Safety.
Compile and maintain regulatory documentation databases or systems.
Recommend changes to company procedures in response to changes in regulations or standards.
Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards.
Prepare responses to customer requests for information, such as product data and written regulatory affairs statements.
Review product labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies.
Advise project teams on subjects such as premarket regulatory requirements, export, and labeling requirements.
Work with the Regulatory Compliance Committee.
Completed a Bachelor’s Degree in Science or Engineering is preferred.
Entry level with interest in Regulatory Compliance.
Communicate effectively, both verbal and written.
Eager to learn and jump into an organization.
Self-sufficient and able to work in a team environment.
Proficiency in computer applications such as Microsoft Word and Excel.
Internal Number: 1
About Compounding Solutions, LLC
Compounding Solutions was started by Scott Neal in 1999 with the sole purpose to become the leading medical compounder. Today it is still owned and operated by Scott Neal. Scott is the son of plastics entrepreneur Robert Neal. Scott began working with plastics processing equipment for blown film applications at the age of 10. Scott is a 1990 graduate from the Whittemore School of Business and Economics, UNH, where he earned a degree in economics and business administration. Scott founded PolyColors Inc immediately following graduation in May of 1990. PolyColors was a custom color master batch manufacturer servicing blown film, injection molding, and profile extrusion plastics processors in the northeast. Scott sold PolyColors to Clariant Masterbatches in 1997 and stayed on until 1999 as general manager. He resigned from Clariant in May of 1999 and founded Compounding Solutions.
In 1999 Compounding Solutions was opened right here at 258 Goddard Rd with a 10,000-square foot building, 2 extrusion lines and 3 employees. Over 4 years Compounding Solutions made head way into the medical market while making an impact in the northeast injection molding market.
In 2004 Compounding Sol...utions expanded its 258 Goddard Rd facility from 10,000 sqft to a 20,000 sqft. We were operating with three twin screw compounding line ranging from 27mm to 50mm. CS grew to 20 employees and was becoming entrenched in the medical industry. CS realized we had to advance our quality system and received our ISO 9001:2008 certification.
Our steady growth had driven us to expand again, beginning in 2010 to 60,000 sqft. In 2017, we began an expansion to 120,000 sq ft. We are now operating 13 compounding lines with over 75 employees in two manufacturing areas, which includes:
> 7,600 sqft controlled environment white room.
> 4,500 sqft controlled environment R&D/quality control laboratory record & retain retention room.
> 2,000 sqft Pete Goguen Innovation Center read more….
CS has become a leader in technology and quality in the medical compounding industry.
The future is bright for Compounding Solutions; we are currently undergoing phase two of our 2017 expansion read more. Compounding Solutions is adding a 60,000 sqft of building to its current facility, more than doubling its current size. In the new expansion, we will be addressing our immediate need for warehouse space for raw materials and finished goods. Secondly, we will be adding 3 new manufacturing areas:
> 6,400 sqft Class 100,000 clean room for medical compounding.
> 3,200 sqft controlled environment white room for Fluoropolymer compounding.
> 8,000 sqft industrial compound manufacturing area.
As 2017 unfolds our facility will have greatly enhanced capabilities to grow with your needs. The expansion will provide space for up to 22 compounding lines! This will essentially complete our footprint and will enable us to make expansions across the US and/or globally as needed. To that end, we added 3 stainless steel pharmaceutical grade compounding lines to the new clean room we will be building designed to help with the drug eluting marketplace and much, much more enabling Compounding Solutions to grow with industry needs and your company.