What are the responsibilities and job description for the GMP Documentation Specialist position at Staffana?
Company Description
Staffana enables organizations to swiftly build highly skilled global teams, reducing the time required from months to just days. The company specializes in streamlining the process of finding, hiring, onboarding, managing, and paying team members while ensuring compliance with local regulations. With cutting-edge technologies, Staffana supports recruitment outsourcing and staffing needs for businesses worldwide. Their core offerings include RPO and Staffing Solutions, Engineering Staffing, Offshore/Nearshore IT Staff Augmentation, Executive Placement Services, and Lead Generation and Appointment Setting.
Technical Documentation Specialist
Location: Greensboro, NC
Work Model: Hybrid
Pay Rate: $35.00–$45.00/hr
Contract Length: 3 months
Client JO#: 4978
Top Required Skills
- Previous Technical Documentation or Document Control experience
- Leadership & Initiative Ownership
- Collaboration & Cross-functional Communication
- Agile / Adaptability to Change
- Operates with Discipline
- Strong Business Mastery & Technical Mastery
- Strong MS Office (Word, Excel, PowerPoint, SharePoint/Office 365)
- GMP/GDP & Quality Systems experience (preferred)
Core Responsibilities
- Organize and maintain an effective document archiving system.
- Label, sort, categorize, and retrieve documents as needed.
- Ensure documentation integrity, accuracy, and regulatory compliance.
- Outline and maintain long-term document storage strategies (physical digital).
- Utilize electronic filing tools/software (e.g., Veeva, Documentum, QUMAS).
- Control access to documents; remove obsolete versions.
- Perform transcription, formatting, conversion, and proofreading tasks.
- Support internal and external audits.
- Maintain consistency in documentation practices across departments.
- Partner with teams to ensure document workflows follow established processes.
Leadership & Execution Expectations
- Execute with Excellence
- Experience in Initiative Leadership, Project Management, Marketing Specialist, Work Process Ownership, or Technical Documentation.
- Demonstrated ability managing multiple complex projects simultaneously.
- Strong urgency, attention to detail, and ability to own processes end-to-end.
- Lead with Courage
- Ability to set priorities, lead others, delegate tasks, and drive accountability.
- Engage cross-functionally with internal teams and suppliers.
- Embraces Change
- Adaptive mindset — open to new workflows, tools, and business needs.
- Collaboration & Communication
- Lead meetings, collect feedback, and convert inputs into action plans.
- Provide clear written updates to teams, leadership, and stakeholders.
- Problem Solving
- Identify issues, perform root cause analysis, assess risks, and recommend corrective actions.
- Champion Productivity
- Analyze data for reporting, gap analysis, loss analysis, and process improvement.
- High proficiency with MS Word, Excel, PowerPoint, Office 365, Visio, Smartsheet.
Quality & Regulatory Skill Requirements (Strongly Preferred)
- Accurate documentation skills
- GMP, GDP, QMS
- FDA 21 CFR Part 210, 211, 820
- Batch Record Review
- CAPA, Deviations, Change Control
- Inspection readiness / PAI preparedness
- Data Integrity, LIMS
- Root cause analysis
- Tools: TrackWise, Veeva Vault, Documentum, QUMAS
Salary : $35 - $45