Regulatory Data Specialist
Harba Solutions Inc., Saint Louis, MO, United States
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
#J-18808-Ljbffr
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
#J-18808-Ljbffr