Quality Consultant (FAR/BPDR)
About the job QSE7, a Pennsylvania-based consulting firm, is seeking to hire an experienced FAR/BPDR Sr. Specialist for a contract engagement with a large pharmaceutical client. The role supports the client's Field Alert Report (FAR) and Biological Product Deviation Report (BPDR) program: screening quality events for potential reportability, documenting FAR decisions, maintaining records in the client's quality system (COMET), coordinating Significant Quality Issue (SQI) escalations, and running a weekly reconciliation that keeps every record complete, timely, traceable and inspection-ready. You will screen, document and coordinate; reportability decisions, dispositions and approvals remain with the client's authorized Quality personnel. You will also help design and implement the standardized process, tools and job aids the team will use going forward. This is a remote position. Job Responsibilities: Screen incoming complaints, nonconformances (NCs) and stability OOS/OOT events for potential FAR/BPDR reportability, working in close collaboration with site SMEs. Record Day 0 evidence at intake and promptly refer potential FAR/BPDR events and urgent gaps to authorized Quality personnel. Track FAR decision forms through completion, coordinate input from the applicable SMEs, and file signed forms and approved rationale in COMET. Maintain accurate, complete COMET records and prevent duplicate entries across related events. Coordinate Significant Quality Issue (SQI) consultations, document approved dispositions, and ensure timely escalation handoffs. Own the weekly reconciliation of source events against assessments, decision forms, COMET records and regulatory submission records. Document reconciliation discrepancies with clear owners and due dates, and escalate urgent items immediately. Maintain approved records through completion or handoff, monitor open actions and timeliness, and support assigned reporting. Apply good documentation practices and data integrity (ALCOA+) principles so every record is complete, traceable and inspection-ready. Co-develop and implement standardized workflows, checklists, reconciliation tools and job aids for the FAR/BPDR process. Identify process-improvement opportunities and build clear reports or dashboards that give Quality leadership visibility into status, timeliness and gaps.
Qualifications
Bachelor's degree in Science, Engineering, Pharmacy, Quality or a related field, or equivalent relevant experience. 5+ years of pharmaceutical or biologics quality experience, ideally with complaints and NCs/deviations. Working knowledge of Field Alert Report (21 CFR 314.81) and/or Biological Product Deviation Report (21 CFR 600.14 / 606.171) requirements strongly preferred. Strong knowledge of good documentation practices (GDP) and data integrity (ALCOA+) expectations. Experience working in electronic quality management systems (e.g., COMET, Veeva QMS, TrackWise or similar). Strong information technology proficiency, including advanced Excel; Power BI, Smartsheet or similar reporting tools a plus. Demonstrated ability to create and maintain clear reports, trackers or dashboards. Strong critical thinking, with the ability to evaluate information from multiple sources, identify trends and gaps, and translate findings into actionable insights. Track record of identifying process-improvement opportunities and helping implement standardized workflows or job aids. Strong cross-functional coordination skills, with disciplined deadline follow-up and sound judgment on when to escalate. Clear, professional written and verbal communication with site SMEs and Quality leadership. About QSE7 - Founded in 2016, QSE7 offers innovative and specialized Information Technology (IT) and Consulting services to FDA-regulated life sciences companies. Our areas of focus include program/project management, process analysis, automated business process improvements, data analytics and reporting, and implementation of IT solutions based on Microsoft technologies, such as Excel, MS Teams, SharePoint, Power BI and Power Automate. We strive to bring automation and efficiency to our clients' processes by providing high-quality and intuitive solutions in an efficient, comprehensive manner.