The Auditor, Quality Compliance supports the Quality Assurance (QA) department within the company to meet planned and systematic activities implemented in the UBC Quality Management System. Requirements:
• Bachelor's degree and 2-5 years' experience, or equivalent years' work experience in regulated industry (e.g. pharma, medical device) or Master's degree and 0-2 year's quality assurance/compliance experience.
• Knowledge of applicable pharmaceutical/biotechnology regulatory requirements, e.g., ICH GCP, FDA, EMA, MHRA, EU GVP is preferred.
• Strong written and verbal communication skills.
• Strong attention to detail.
• Computer skills experience with proficiency in Microsoft Office Suite (i.e. Word, PowerPoint, Excel, Outlook).
• Ability to communicate effectively and professionally across all levels of the organization including clients/sponsors and regulatory auditors.
• Capable of ensuring confidentiality and using discretion. Demonstrates a high level of integrity.
• Must be able to manage multiple tasks and competing priorities in accordance with business needs.
• Demonstrates initiative and ability to work independently and under limited supervision.
• Travel as necessary, expected 10-20%Desired:
• Experience conducting internal file and/or process audits.
• Experience hosting client audits and s regulatory inspections.
• Experience in conducting third party vendor assessments.
• Quality management experience with focus on process improvement. Demonstrated experience in planning, analysis and problem solving.
• Experience in management of Corrective and Preventive Action (CAPA) documentation including determining Root Cause Analysis (RCA) and conducting effectiveness assessments.
• Experience in management of Standard Operating Procedures (e.g., writing and reviewing).
• Experience in the review of clinical documents (e.g., clinical study reports, protocols, safety reports, project-specific procedures).
• Exposure to software application development and maintenance.Supervisory Responsibilities:
NoneSpecific Job Duties:
• Responsible for ensuring that the company's quality systems and procedures meet U.S. and international regulatory requirements (e.g. FDA/CFR, GxP, EMA, MHRA, EU GVP) as applicable for the business.
• Conduct internal pharmacovigilance audits in accordance with the Quality Management System for Pharmacovigilance
• Perform internal file and process audits to ensure compliance with Standard Operating Procedures, contractual requirements as well as applicable regulatory requirements.
• Conducts or assists with Quality Assurance Audits of Investigator sites and/or third party vendors to ensure compliance with applicable regulations and guidelines
• Prepares audit report and tracks follow-up actions.
• Identifies, evaluates and addresses quality issues. Guides process owners in Root Cause Analysis and facilitates completion of Corrective and Preventive Action (CAPA) documentation.
• Responsible for CAPA management within the UBC CAPA database.
• Ability to identify and facilitate process improvement opportunities.
• Assist with development and maintenance of standard operating procedures. Conducts review of project-related and/or application validation documentation.
• Perform additional quality assurance/control activities as needed.
• Assist other department members as requested. Team player with good interpersonal skills.
• Conducts quality review of project deliverables (e.g., clinical study reports, protocols, tables/listings/figures, narratives, data collection tools, safety reports, project-specific procedures/plans).
• Conducts staff training as needed. Assist with review and/or maintenance of training records as applicable.
• Hosts or assists with hosting regulatory & client inspections at the company's facilities, as needed.
• Supports third party quality audit activities, schedules, facilitates internal communication and tracks follow-up actions.
• Other duties as assigned by management
United BioSource Corporation (UBC) is a leading provider of pharmaceutical support services, partnering with life science companies to make medicine and medical products safer and more accessible. Our services support the full lifecycle of medicine and medical products, including development, commercialization, and long-term value and safety.
While UBC offers employment within Patient Support, Nursing, Pharmacy and Corporate, two main focus areas for the company are Clinical Development & Research and Safety & Risk Management. Members of the Clinical Development and Research teams help evaluate study protocol, target study population, recruit physicians and patients, and collect, clean, validate and report data. As a result, sponsors are able to submit findings to regulatory authorities or make a no-go decision in a timely and clear-cut manner. Additionally, our Safety and Risk Management teams develop, deliver, and report evidence to reinforce safe and appropriate product use.
Through our Patient Access services, we help patients begin therapy quickly and remain on therapy, building strong relationships with patients to ensure optimal care.
You can find out more by visitingwww.ubc.com