10 months ago
Analytical Data Reviewer
Are you looking to make a career change to a rapidly growing, stable, and professional company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance, vision insurance, and paid PTO. Does this position match your future career goals? Then this opportunity could be the right fit for you.
- Performs review of laboratory notebooks, analytical data, protocols and analytical reports from both QC and AR&D area.
- Ensures that the analytical data generated is on par with regulatory requirements
- Plans and organizes daily activities of data review with co-ordination of QC supervisor on priorities.
- Ensures all testing/analysis is conducted according to approved test methods, standard operating procedures or associated documents and meets the product specific requirements.
- Demonstrated ability to write scientific and other technical reports and protocols.
- Must be familiar with the different kinds of calculations that used in pharmaceutical industry.
- Checks all the laboratory notebooks for correctness of raw data and verifies all reagents, standards and equipment used are within the acceptable range.
- Review the HPLC, GC related raw data for its audit trails and instrument logs on cGMP instrumentation and equipment for laboratory data release.
- Monitoring of Non-Conformance Event in the laboratory, Out of Trend, and Out of Specification.
- Reviews Raw materials, in-process, finished product and stability study analysis.
- Review of stability study protocols, stability reports and monitoring related trend reports.
- Perform trending on data review observations and conduct training to reduce the laboratory documentation errors and providing continuous updates on this to the QC management.
- Support QC and QA managements during regulatory, customer, corporate, and internal audits.
- Work with analysts for document corrections and provide guidance accordingly. Guide analysts on laboratory notebook documentation requirements.
- Providing the required support during the regulatory audits and internal audits.
- Performs other duties and projects as assigned by management.
- Bachelor's or Master’s degree in science, related field or equivalent
- At least 4 years of experience within the US pharmaceutical industry or equivalent in the area of quality control.
- Must be familiar with a different type of analytical equipment, practices, procedures, and the regulatory framework in the area of pharmaceutical industry.
- Experience and knowledge of the operating principles of HPLC, Dissolution, GC, UV, FT-IR, Malvern master sizer and data software Empower.
- Must be familiar with the USP, ICH and FDA regulations and guidelines on pharmaceuticals products analysis.