Wipe up at brand new facility and see your clean path to history!
Rockline Industries announced it has formed a new subsidiary, Iatric Manufacturing Solutions, dedicated to helping foster healthy environments through the design and manufacturing of FDA-regulated wipes for use in the consumer, health care, food service, and hospitality industries. Iatric will operate out of a new 435,000-square-foot state-of-the-art FDA-registered facility in Morristown, TN. The wholly owned subsidiary was born out of the rapidly increasing demand for Rockline’s innovative wet wipes products that are designed to support healthier, sanitary environments and personal hygiene. The new plant will be operational beginning in 2018 and is expected to employ 250 people. The Quality Assurance Manager will develop the site Quality System and build a high performing team to guarantee that every Iatric product made delights our customers and satisfies regulatory guidelines.
The Quality Assurance Manager will establish the Quality System at a brand-new facility. The Quality Assurance Manager will become a strategic member of the Iatric Leadership team and develop initiatives that support company and facility goals. In short, you will build the systems and hire the people that ensure safety of all Iatric products.
Quality Assurance Manager Key Performance Objectives
- Major Objective: Support the launch and startup of the brand-new OTC regulated facility to be fully operational by April 1st, 2018. Establish a plan to transfer technology and a portion of production converting methods from Rockline Industries’ Sheboygan, WI facility to Iatric Manufacturing Solutions in Morristown, TN.
- Complete the plan to validate equipment: Lead, facilitate and complete the plan to validate new and existing equipment. As part of the startup of Iatric, production will transfer from contract manufactures and existing Rockline facilities over the first two years of production. Prepare and present the detailed plan for the validation to executive leadership. Include in this report all resource needs (equipment, staff, budget) to meet the completed plan.
- Plan for staffing structure and filling roles: Take the lead on, with the guidance/assistance from Site General Manager, determining the plan for Quality Assurance and Control staffing structure. Hire and build out the Quality Assurance and Control teams to support startup timeline.
- FDA Process and regulation Mapping: Map out the product safety plan to meet FDA regulatory and customer expectations. Understand OTC/contract manufacturing strategies, customers, and product mix for Iatric. As part of this, identify critical challenges and short opportunities that can be quickly addressed.
- Implement an impactful QA system: In collaboration with the Global Quality Assurance department, develop a detailed QA process improvement plan gaining full commitment and support from the entire team. Learn the mechanics through the converting process and gain knowledge of associated safety and the quality systems.
- Setup Quality Control Laboratory: Complete the build out of raw material and finished good laboratories to evaluate product efficacy. Research and propose needed lab equipment to support plant startup.
- Bachelor’s Degree (BS) with a major in an engineering, scientific, or related technical discipline.
- 7+ years progressive Quality Assurance experience in key leadership/management role(s) in Medical Device and/or Pharmaceutical FDA regulated environment(s).
- Previous experience hosting FDA and other regulatory audits is required.
- Previous FDA Quality System Management experience and experience with/understanding of microbiology are highly desired.