Risk Documentation Analyst

Located in Birmingham, AL

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:

• Monday–Friday, 8:00 AM–5:00 PM

• On-site, full-time

• Temp-to-perm opportunity

• Pay range: $24–$27/hour

Key Responsibilities:

Investigation & Risk Analysis

• 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 and regulatory documentation

• Maintain risk registers, quality management systems, and compliance records

Reporting & Collaboration

• 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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