Katherine Schreier Email & Phone Number

Huntsville, Alabama Area

Huntsville, Alabama Area

Huntsville, Alabama Area

•Supervise Regulatory Affairs Specialists, prioritize projects, provide training for assessment of change control documentation, review annual reports, periodic safety reports, supplemental applications, original ANDA documentation, and deficiency responses.•Review and assess change control documentation for master batch records, raw material specifications and test methods, finished product specifications and test methods, and packaging components.•Write and revise SOPs and work instructions.•Write and review CMC documentation for original ANDA applications and amendments, supplemental applications, and annual reports.•Publish ANDA submissions in eCTD format for submission through the electronic submissions gateway.•Lead inter-disciplinary project teams to coordinate and write responses to information request and complete response letters.

Huntsville, Alabama Area

•Responsible for the preparation of original ANDA submissions including review of documentation, compilation, and writing of CMC sections. •Participated on inter-disciplinary teams to coordinate and write responses to deficiency letters.•Prepared ANDA annual reports, periodic safety reports, and supplements.•Publish submissions in eCTD format for submission through the electronic submissions gateway.

Greenville, South Carolina Area

•Audited analytical data for accuracy, completeness, conformance to specifications, and compliance to SOPs and cGMPs.•Wrote analytical methods, validation documents and change control documentation. •Analyzed in-process production samples using HPLC, KF, and moisture balance.

Florence, South Carolina Area

•Analyzed R & D materials, pilot scale production materials, in-process samples, stability samples, and raw materials by HPLC, GC, IR, UV-Vis, and KF. •Optimized and validated gravimetric analysis, HPLC and GC methods. •Maintained and troubleshot instrumentation. •Wrote and revised analytical procedures, validation documents and reports.

West Lafayette, Indiana

•Provided technical support for the technicians in the HPLC area of the QC Lab. •Optimized and validated HPLC methods. •Facilitated transfer of new HPLC methods into the laboratory. •Troubleshot problem assays.•Performed analytical investigations of out-of-specification results, control chart trends and stability sample data.•Worked in interdisciplinary teams to support investigations of production upsets and new drug speed-to-market initiatives.•Wrote procedures, protocols, and reports.•Maintained documentation in accordance with requirements of regulatory agencies.