Risk Documentation Analyst

Our client is a pharmaceutical company in the Birmingham area that operates as an outsourcing compounding facility specializing in hormone and therapeutic wellness. They partner with healthcare providers to deliver high-quality, customized medications while maintaining strict quality, safety, and regulatory standards. Position Overview: The Risk Documentation Analyst is an investigative, documentation-focused role supporting quality, compliance, and risk management efforts within a regulated pharmaceutical environment. This position blends administrative expertise with analytical thinking and production-floor exposure, requiring strong documentation management skills, regulatory awareness, and the ability to assess and communicate risk effectively. Schedule & Pay: Monday–Friday, 8:00 AM–5:00 PM On-site, full-time Temp-to-perm opportunity Pay range: $24–$27/hour Key Responsibilities Investigate product complaints, adverse events, quality deviations, and potential non-compliance Perform root cause analysis using documentation, data, and system records Identify operational, financial, and patient-impact risks through trend analysis and data review Extract, validate, and analyze datasets from quality systems, complaint logs, and related sources Documentation & Compliance Manage and maintain high-risk documentation in alignment with SOPs and regulatory standards Understand how SOPs are impacted by change and ensure documentation remains current and compliant Author and support technical writing for quality, training, and regulatory documentation Maintain risk registers, quality management systems, and compliance records Create clear, comprehensive reports and summaries for internal leadership and stakeholders Support documentation for regulatory submissions, including stability-related content Collaborate with production, quality, and cross-functional teams; maintain some presence on the production floor Support quality and compliance initiatives through accurate documentation and reporting Qualifications & Experience Strong understanding of SOPs and documentation management in regulated environments Experience with investigations, risk assessment, or quality documentation preferred Ability to interpret and analyze high-risk or complex documentation Strong analytical, organizational, and technical writing skills Comfortable working both administratively and on the production floor Pharmaceutical or regulated industry experience preferred Detail-oriented, inquisitive, and capable of independently driving investigations

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