Data Integrity Specialist
About the Role
To Apply for this Job Click Here
Summary of Position
The Data Integrity Specialist will support electronic and paper-based systems.
Essential Functions
- Research Laboratory and Manufacturing processes to develop compliance gap assessments related to data integrity.
- Understand Laboratory and Manufacturing data life cycles to develop data maps.
- Report on progress of data integrity work and significance of the results.
- Complete Periodic System Reviews according to schedule, working with system administrators and subject matter experts to accurately assess the systems and the associated data.
- Assess risks related to data integrity and collaborate with colleagues to mitigate and implement appropriate corrective actions.
- Assist Laboratory and Manufacturing personnel with development of procedures, job aids and other documentation to improve the overall site compliance stance.
- Perform data integrity training using approved course curriculum
- Utilize expertise and information on data integrity to assist Laboratory and Manufacturing personnel on compliance issues.
- Maintain current knowledge of federal and international data integrity regulations.
- Work independently and manage workload.
- Manage and prioritize project in an organized and structured manner.
- Maintain the required percentage complete on all assigned site training.
- Perform all work in compliance with site safety and radiation protection guidelines.
- Author standard operating procedures.
- Create data maps for laboratory and manufacturing systems.
- Assist site staff in adherence to national and international regulatory guidelines on Electronic Records and Electronic Signatures and Data Integrity, cGMP, FDA 21 CFR Part 11/210/211, EU Annex 11, MHRA and GAMP5 guidelines.
- Must maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, EU, HC, TGA, PIC/S, ISO, USP, NRC, cGMP, etc.).
- All other responsibilities as assigned with or without accommodation.
Requirements
- Bachelor Degree preferred. Work experience is considered in lieu of degree.
- Three or more years of relevant work experience required.
- Candidates must understand how to apply regulations within manufacturing and laboratory environments.
- Experience reviewing / authoring standard operation procedures.
NJN1453679AJ_1780322533
To Apply for this Job Click Here
Excited about this job?
Don’t wait — Step into a role that matches your potential!
Explore Similar Roles
See more jobs like this in your inbox weekly.
Share this Role
Other jobs you might like...
What job seekers like you say about working with Beacon Hill…
Substance. Scale. Synchrony.
Beacon Hill is an Equal Opportunity Employer that values the strength diversity brings to the workplace. Individuals with Disabilities and Protected Veterans are encouraged to apply.
Founded by industry leaders to set a new standard in search, career placement and flexible staffing, we deliver coordinated staffing solutions with unparalleled service, and a passion for innovation, creativity and continuous improvement.
Our niche brands offer a complete suite of staffing services to emerging growth companies and the Fortune 500 across market sectors, career specialties/disciplines and industries. Over time, office locations, specialty practice areas and service offerings will be added to address ever changing constituent needs.
We look forward to working with you.