What are the responsibilities and job description for the Regulatory Data Specialist position at Harba Solutions Inc.?
Key Responsibilities:
- Assess laboratory and manufacturing systems for alignment with data integrity and regulatory requirements
- Lead or support structured compliance reviews and risk-based evaluations
- Develop data flow documentation outlining system inputs, transformations, controls, and archival processes
- Perform scheduled system oversight reviews in coordination with system owners
- Evaluate audit trails and electronic record controls to ensure traceability and completeness
- Author and revise SOPs, work instructions, and governance documentation
- Support corrective and preventive actions tied to data integrity findings
- Provide training and guidance on regulatory expectations related to electronic records and documentation controls
- Partner cross-functionally with Quality, Operations, IT, and Validation teams
- Maintain working knowledge of evolving global regulatory guidance
Qualifications:
- Bachelor’s degree in a scientific, engineering, or related discipline (experience may substitute)
- Minimum 3 years in a GMP-regulated pharmaceutical, biotech, or medical device environment
- Practical experience applying data integrity principles within laboratory or manufacturing systems
- Familiarity with electronic records regulations (e.g., 21 CFR Part 11, EU Annex 11)
- Exposure to system lifecycle management and/or computer system validation
- Experience authoring and reviewing controlled documentation
- Strong analytical skills with the ability to assess risk and drive resolution
- Effective communicator with the ability to influence across departments