Quality Assurance Data Reviewer

• 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.

• 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.

Pulled from the full job description

• 401(k)
• Health insurance
• Paid time off
• Vision insurance
• Dental insurance
• Flexible spending account
• Life insurance, * 401(k)
• Dental insurance
• Employee assistance program
• Flexible spending account
• Health insurance
• Life insurance
• Paid time off
• Vision insurance