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Quality Assurance Manager - QA / QC Regulatory Affairs

Company: The Assistant Company
Location: Pahrump
Posted on: October 17, 2020

Job Description:

The Assistant Company has been hired by a top Las Vegas Manufacturer who is seeking a Quality Assurance Manager with a strong understanding of FDA Quality GMP regulations for the client and over-the-counter (OTC) cosmetic and medical device products. The Quality & Regulatory Manager will be responsible for assisting, supporting and maintaining procedures in the Quality and Regulatory Affairs department to ensure global compliance of products. The Quality & Regulatory Manager will report to the President, in addition to working with the Warehouse Receiving, Inventory control, Production Supervisors, Director of Operations, Purchasing Director, and the PD team on any ad hoc projects that may arise. RESPONSIBILITIES: System administrator for electronic Quality Management System (QMS) Stability program manager (including compatibility test samples and reports) Perform executed batch record review/approval and lot disposition (including receipt and approval of all Certificate of Analysis (COAs)) Write/Review/approve non-conformances and generate Corrective and/or Preventive Action (CAPAs) as needed Follow-up on GMP vendor/supplier audit observations Generate quality metrics/KPIs for Quality Management Review meetings Write quality investigation reports Approval of Ingredient Lists for Product Labels Manage Product Dossiers Manage testing POs and review/track invoices for approval Analyze PET, RIPT, Ocular, Micro, SPF and any other required product test results Regulatory Formula Review for compliance with US, Canada and Australian regulations Control of Safety Data Sheets (SDS) Write/Review QA/QC Standard Operating Procedures (SOPs) Review other departmental SOPs and provide critical compliance-based feedback Stay current on FDA, Nevada regulatory/legislative activity Review and Approve label artwork for accuracy and ensure all label requirements are met Experience with 510(k) submissions for class II devices. Strong knowledge of Medical device FDA QSRs, ISO 13485, Technical Files, CE Marking (MDD), and international registrations of medical devices. Versed in regulatory requirements for all countries, including but not limited to: US FDA, Canada REQUIREMENTS: Working knowledge of manufacturing Self-Directed and Proactive self-starter Highly Organized, Proficient with strict attention to detail Ability to multi-task error free Excellent time-management skills and ability to work under pressure 5+ years of experience in an FDA-Regulated industry, preferably cosmetics and/or OTC cosmetics products and medical devices Experience with GMPs, FDA guidance documents and Nevada state legislative regulations Bachelors Degree or Equivalent (Science background is a plus) Proficiency with Microsoft Outlook, Word and PowerPoint, Excel, Workfront, and SAP Experience with both paper and electronic QMS systems a plus EMAIL: info@theassistantcompany.com Keywords: QA, QC, quality control, QA/QC Regulatory Affairs,

Keywords: The Assistant Company, Las Vegas , Quality Assurance Manager - QA / QC Regulatory Affairs, Executive , Pahrump, Nevada

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