Job 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:
- 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, training, 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
Job Tags
Permanent employment, Full time, Temporary work, Monday to Friday,