Title: Global OTC Program Coordinator Reports to: Head of Quality Department: Quality Assurance/ Quality Control/ Regulatory Responsibilities: + Facilitate communication between the three OTC Factories (Sites) to support smooth, quick sharing of OTC Quality and Regulatory information, data, results and reports. + Facilitates the timely and accurate response to each Factory’s requests with regards to Quality / GMP documents, samples management, and communications as it relates to quality responsibilities, including the release of RMs, intermediates, bulk & FGs; and regulatory communications. + Ensure accuracy and completeness of all quality documents forwarded to each Factory. + Review and facilitate the forwarding of samples to testing sites, communication of test reports, mediation to resolve missing documents or test requirements, and follow-up to complete resolutions of open OTC issues between the Sites. + Participate in site calls, meetings, conference calls as the Quality liaison to support new launches, scale-ups, process/system validations, investigations, audits and inspections. + Assist, as needed, R&D, Customer Service (CSRs), Process Engrg, etc., to expedite cross-Factory OTC requests. + Maintain tracker of open quality issues as the related to cross-factory activities. + Update/Upload data, results, reports, etc., to each Factory’s ERP/Quality system, via their portal. + Support inspections and investigations related to OTCs. + Support special Regulatory request as needed. + Support sharing and transmission of draft and approved OTC formulas, Batch Procedures, Specifications, etc. + Support new OTC projects and Line trials. + Any additional duties of assignments as directed by the Supervisor or QA Manager. + Familiarity with OTC/US FDA 21CFR Part 210 & 211 and Cosmetic GMPs is required. Requirements + Minimum of Associate or Bachelor degree (Life Sciences, Engineering, related profession). + Five+ years industry or related experience in cosmetic, device, food, or pharma. + Previous inspecting, auditing or manufacturing experience - a plus. + Data analysis, specification development skills. + Computer literate and effective communication skills. Benefits + Medical, Dental, and Vision Insurance + Life Insurance + 401k match