Express Employment Professionals - Birmingham, AL South ยท 1 day ago
Risk Documentation Analyst
Birmingham, AL
Contract
Onsite
New Grad, Entry Level
$24/hr - $27/hrExpress Employment Professionals is representing a pharmaceutical company in Birmingham, specializing in hormone and therapeutic wellness. The Risk Documentation Analyst will support quality, compliance, and risk management efforts, requiring strong documentation management skills and the ability to assess and communicate risk effectively.
Staffing & Recruiting
Hiring Manager
Katie Day
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
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
Qualification
Required
Strong understanding of SOPs and documentation management in regulated environments
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
Detail-oriented, inquisitive, and capable of independently driving investigations
Preferred
Experience with investigations, risk assessment, or quality documentation
Pharmaceutical or regulated industry experience
Company
Express Employment Professionals - Birmingham, AL South
Express Bham South is proud to serve our community by helping people find jobs and helping businesses find the people and human resource services they need.
Founded in 2006
2-10 employees
Funding
Current Stage
Early StageCompany data provided by crunchbase