Global OTC Program Coordinator

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.

• 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.

• Medical, Dental, and Vision Insurance
• Life Insurance
• 401k match