Located in Birmingham, AL
Job Full Description
Job Title: Risk Documentation Analyst
About the Company:
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:
Key Responsibilities:
Investigation & Risk Analysis
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Investigate product complaints, adverse events, quality deviations, and potential non-compliance
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Perform root cause analysis using documentation, data, and system records
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Identify operational, financial, and patient-impact risks through trend analysis and data review
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Extract, validate, and analyze datasets from quality systems, complaint logs, and related sources
Documentation & Compliance
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Manage and maintain high-risk documentation in alignment with SOPs and regulatory standards
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Understand how SOPs are impacted by change and ensure documentation remains current and compliant
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Author and support technical writing for quality and regulatory documentation
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Maintain risk registers, quality management systems, and compliance records
Reporting & Collaboration
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Create clear, comprehensive reports and summaries for internal leadership and stakeholders
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Support documentation for regulatory submissions, including stability-related content
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Collaborate with production, quality, and cross-functional teams; maintain some presence on the production floor
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Support quality and compliance initiatives through accurate documentation and reporting
Qualifications & Experience:
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Strong understanding of SOPs and documentation management in regulated environments
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Experience with investigations, risk assessment, or quality documentation preferred
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Ability to interpret and analyze high-risk or complex documentation
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Strong analytical, organizational, and technical writing skills
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Comfortable working both administratively and on the production floor
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Pharmaceutical or regulated industry experience preferred
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Detail-oriented, inquisitive, and capable of independently driving investigations
Birmingham (South), AL
3348
200 Cahaba Park Circle
Suite 130
Birmingham, AL 35242
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