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# Quality Assurance Data Reviewer

- **Company:** I 3 Pharmaceuticals, LLC
- **Location:** Warminster, PA, United States
- **Experience:** Expert
- **Salary:** $65,000.0 - $80,000.0
- **Contract:** Permanent contract
- **Skills:** Microsoft Word, Microsoft Excel, Data Analysis, Microsoft PowerPoint, Iq/oq/pq, Model Validation
- **Published:** July 18, 2026
- **Apply:** https://www.indeed.com/viewjob?jk=c8047e7b6657f2d9

## About the Role

* Bachelor's Degree in Chemistry, Pharmaceutical Sciences, Biology or equivalent is required.
 * Master's Degree in any of the above disciplines is preferred
 * 5 years of pharmaceutical industry experience required.
 * Proficiency is writing and reviewing reports, protocols and SOP's, and in filing ANDAs.
 * GLP/cGMP documentation experience is a must.
 * Prior experience reviewing laboratory and manufacturing deviations and investigations.
 * Knowledge of QA systems.
 * Excellent verbal and written communications skills.
 * Strong interpersonal and relationship building skills.
 * Proficient in Microsoft Word, Excel and PowerPoint.

## Description

* Review laboratory notebooks and all analytical data originating from in-house and outside contact testing labs.
 * Review ·analytical method validation/protocols, method verification protocols/ reports, draft methods, and other relevant analytical data.
 * Review calibration data of laboratory equipment to ensure compliance with SOPs, CGLP and cGMP.
 * Ensure all lab and manufacturing related documentation is current, accurate and in the manner required.
 * Ensure all activities related to stability testing are complete within the stability timeframe.
 * Prepare and review the stability data, stability summary reports, certificate of analysis and any documentation required for filing of ANDA''s.
 * Review all compendial methods and procedures, as needed.
 * Review laboratory related deviations, OOS, OOT and other investigations.
 * Review and maintain all documentation (equipment qualifications, calibration reports, archived logbooks\ notebooks, GMP documents, etc.).
 * Review all production/analytical equipment qualification (IQ/OQ/PQ) and calibration documents.
 * Review batch evaluation protocols/reports, batch records and other production related documents, as needed.
 * Review manufacturing deviations and investigations.
 * Ensure all activities are documented in a legible manner following established formats and good documentation procedures.
 * Coordinate the review of ANDA projects as per priority.
 * Draft, review and update ·SOPs to be compliant with the current regulatory guidance and provide official copies of approved documents to the respective departments, as needed.
 * Review QA systems and identify gaps for remediation.
 * Promote an environment of continuous improvement and enhance efficiency & effectiveness of the data review process
 * Perform other duties as assigned.


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