Job Title: Quality Management System (QMS) Analyst Type: Full-time Location: Remote Experience: 0–2 Years Job Summary: We are seeking a detail-oriented and organized Entry-Level Quality Management System (QMS) Analyst to support the administration, maintenance, and continuous improvement of quality systems within the pharmaceutical and life sciences industry. The selected candidate will assist with managing controlled documents, tracking deviations and corrective actions, monitoring change controls, and maintaining quality records in electronic quality management systems. This role is ideal for recent graduates interested in pharmaceutical quality operations, regulatory compliance, and quality system management. Key Responsibilities: QMS Administration: Support daily quality management system activities, ensuring that quality records, workflows, and assigned tasks are maintained accurately and completed within established timelines. Electronic Quality Systems: Assist with maintaining records in electronic QMS platforms, including document management, training records, deviation tracking, and corrective and preventive action (CAPA) modules. Document Control: Help prepare, review, route, and maintain controlled documents such as SOPs, work instructions, policies, forms, and quality manuals. Deviation Management: Track quality events, nonconformances, and deviations; verify that required documentation is complete and route records to the appropriate personnel for review. CAPA Tracking: Monitor corrective and preventive action items, update status trackers, follow up on overdue tasks, and support the collection of evidence for effectiveness checks. Change Control Coordination: Assist in maintaining change control records, tracking approvals, and coordinating documentation updates associated with changes to processes, equipment, systems, or procedures. Training Compliance: Maintain employee training matrices, track assigned quality training, and assist with follow-up on overdue training activities. Quality Metrics and Reporting: Compile data on deviations, CAPAs, change controls, document revisions, and training completion to prepare periodic quality performance reports. Audit Readiness: Organize quality records and supporting evidence for internal audits, client audits, and regulatory inspections. Data Integrity: Review quality records for completeness, consistency, traceability, and compliance with Good Documentation Practices (GDP) and applicable data integrity principles. Continuous Improvement: Assist with identifying recurring quality issues, analyzing basic trends, and recommending improvements to quality workflows and documentation practices. Cross-Functional Coordination: Collaborate with Quality Assurance, Quality Control, Manufacturing, Regulatory Affairs, and other departments to resolve documentation gaps and maintain quality system compliance. Required Skills: Bachelor's or Master's degree in Pharmaceutical Sciences, Pharmacy, Biotechnology, Chemistry, Biology, Microbiology, Quality Management, Biomedical Sciences, or a related discipline . Basic understanding of pharmaceutical quality management systems and regulated industry documentation. Familiarity with cGMP, GDP, SOPs, deviations, CAPA, change control, and document control principles. Awareness of FDA regulations and pharmaceutical quality requirements. Basic understanding of electronic document management systems or electronic QMS platforms is an advantage. Ability to maintain accurate records, monitor deadlines, and follow up on outstanding quality actions. Strong analytical skills with the ability to organize data and identify basic trends. Proficiency in Microsoft Excel, Word, and PowerPoint for tracking, documentation, and reporting. Excellent written communication, organization, and attention to detail. Ability to collaborate with multiple departments and handle quality documentation responsibly. Preferred: Academic projects, internships, or exposure to pharmaceutical QA, quality documentation, compliance monitoring, audit preparation, or electronic quality systems. #J-18808-Ljbffr
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