How can you make a difference in this role?
The Quality Data Reviewer is responsible for reviewing quality data and compiling stability reports, COAs, and data summaries.The individual will assist in writing investigations and CAPAs and works with Quality Assurance to ensure timely release and closure of all stability batches.
What are the key responsibilities of this role?
· Review quality data and reports (including stability and release) for compliance against specifications, GMP regulations, and scientific technique.
· Authors stability reports, COAs, data summaries, Standard Operation Procedures, deviation and OOS investigation reports as needed.
· Provide training and guidance to other analysts on an as needed basis.
What experience and job knowledge do you need to excel in this role?
· Degree in a Scientific discipline, Chemistry preferred, with 3-5 years of experience as a QC Chemist/Analyst
Experience and familiarity with analytical testing equipment and methodology including HPLC, Karl Fischer, Spectrophotometry (UV/VIS), and proficient in LCMS analysis and applications.
Familiarity with ICH and CFR guidance's.
Equal Opportunity Employer