GMP Analytics Scientist II — Data Integrity & Validation
RXinsider LTD.
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Job summary
RXinsider LTD. seeks a detail-oriented analytical data reviewer for cGMP-compliant laboratory work in North Carolina. You will review data, verify specifications, and ensure accurate entry into LIMS/SLIM, while coordinating with the Project Lead and training staff as an SME.
The role emphasizes data trending, regulatory compliance with ICH, USP/EP, GMP, and opportunities to contribute to CAPA and SOPs. Fluent English and strong organizational skills are essential in a fast-paced, collaborative
Qualifications
- Associates degree in a scientific discipline; bachelor’s preferred.
- 5 years pharma experience with cGMP data review (or 3+ with BSc).
- 3+ years reviewing data for cGMP compliance and data integrity.
Responsibilities
- Perform cGMP analytical data review to ensure adherence to procedures, standards, GVLs and SOPs.
- Determine if reported data meets specifications or expected standards.
- Verify data entry into LIMS/SLIM and related software.
- Trend data to ensure requirements are met.
- Ensure laboratory activities comply with ICH, USP/EP, GMP and data integrity.
Skills
Education
Tools
Job description
RXinsider LTD. seeks a detail-oriented analytical data reviewer for cGMP-compliant laboratory work in North Carolina. You will review data, verify specifications, and ensure accurate entry into LIMS/SLIM, while coordinating with the Project Lead and training staff as an SME.
The role emphasizes data trending, regulatory compliance with ICH, USP/EP, GMP, and opportunities to contribute to CAPA and SOPs. Fluent English and strong organizational skills are essential in a fast-paced, collaborative
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