Staqpharma
Quality Assurance Manager
Staqpharma, Denver, Colorado, United States, 80285
STAQ Pharma is currently hiring for a Quality Assurance Manager in our Denver FacilityThe Quality Assurance Manager provides leadership in the implementation and oversight of the Quality Management System (QMS) at STAQ Pharma, Inc.This role gives guidance for resolution of daily quality issues and opportunities for improvement to ensure Current Good Manufacturing Practices (CGMP) compliance.Large scale enhancement projects to improve process inefficiencies, eliminate risk, and drive towards may be led by the Quality Assurance Manager.The position leads regulatory inspections and customer audits, and facilitates the supplier management program to ensure the quality of services and incoming goods. Roles and
ResponsibilitiesAuthor, review and/or approve Standard Operating Procedures (SOPs) and Work Instructions to maintain compliance with CGMP requirements and product quality standards.Oversee the batch review and disposition process to ensure products meet CMGP requirements and all unexplained discrepancies are investigated.Manage Quality department metrics for Management Review and routine Key Performance Indicators (KPIs).Serve as QA subject matter expert during regulatory inspections and customer audits. Maintain company audit readiness and support document requests made during inspections and audits.Perform and/or review deviation and CAPA investigations for root cause analysis, corrective actions, and effectiveness checks. Drive CAPA plans to completion in a timely manner.Plan, maintain, and implement the internal audit schedule and ensure audits, responses, and corrective action is taken in a timely manner.Lead the supplier management program to evaluate new suppliers, perform ongoing oversight of suppliers including audits, communicate complaints, and manage supplier corrective action requests.Review change controls to manage the risk and impact to validated CGMP systems, processes, and equipment.Support Quality and company goals related to the QMS.Coach and mentor Quality Assurance department staff to support and execute CGMP processes.Other duties as assigned.Qualifications and Education Requirements5 to 7 years experience in a CGMP environment, preferrably in a decision making or leadership role.B.S. or B.A., at a minimum.Comprehensive knowledge of applicable FDA regulations and guidance documents.Previous experience as a key member of regulatory inspections and customer audits.Strong analytical knowledge of data and associated statistical tools.Technical writing skills to accurately convey information to the intended audience.Preferred SkillsExperience implementing lean manufacturing and 5S methodologies.Advanced Microsoft Office product skills (e.g., Word, Excel).
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ResponsibilitiesAuthor, review and/or approve Standard Operating Procedures (SOPs) and Work Instructions to maintain compliance with CGMP requirements and product quality standards.Oversee the batch review and disposition process to ensure products meet CMGP requirements and all unexplained discrepancies are investigated.Manage Quality department metrics for Management Review and routine Key Performance Indicators (KPIs).Serve as QA subject matter expert during regulatory inspections and customer audits. Maintain company audit readiness and support document requests made during inspections and audits.Perform and/or review deviation and CAPA investigations for root cause analysis, corrective actions, and effectiveness checks. Drive CAPA plans to completion in a timely manner.Plan, maintain, and implement the internal audit schedule and ensure audits, responses, and corrective action is taken in a timely manner.Lead the supplier management program to evaluate new suppliers, perform ongoing oversight of suppliers including audits, communicate complaints, and manage supplier corrective action requests.Review change controls to manage the risk and impact to validated CGMP systems, processes, and equipment.Support Quality and company goals related to the QMS.Coach and mentor Quality Assurance department staff to support and execute CGMP processes.Other duties as assigned.Qualifications and Education Requirements5 to 7 years experience in a CGMP environment, preferrably in a decision making or leadership role.B.S. or B.A., at a minimum.Comprehensive knowledge of applicable FDA regulations and guidance documents.Previous experience as a key member of regulatory inspections and customer audits.Strong analytical knowledge of data and associated statistical tools.Technical writing skills to accurately convey information to the intended audience.Preferred SkillsExperience implementing lean manufacturing and 5S methodologies.Advanced Microsoft Office product skills (e.g., Word, Excel).
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