Quality Systems Specialist

Quality Systems Specialist Position

Reports to Quality Coordinator



Function: Gather and analyze data and report findings to management to facilitate decision-making. Support Quality Systems management in all areas of record maintenance. Responsible for preparation, during and following regulatory inspections. Review and release data to clients’ as required.

 

Accountabilities:

 Review LyMix, Compounding, Fill & Packaging and Irradiation documentation for accuracy and completeness and compliance to DPT and cGMP requirements.Verify that all Bulk and Finished Product testing (analytical and Microbiology) has been completer and is within specifications.Prepare and issue Certifications of Compliance and/or Certificates of Analysis, as required. Review and release lab data to clients. Develops and maintains expertise in cGMP, QSR, TrackWise, iLearn@DPT, QIS, Baan and other QS computer systems as identified to support company objectives. Use quality tools like process mapping, FMEA, Cause and Effect, Pareto analysis. Etc to analyze processes and develop improvement opportunities. Participate on Process Improvement teams representing QS as needed.Use Access, Excel and other systems to support QS and company objectives.Within areas of responsibility, understand and comply with all DFB Pharmaceuticals, Inc, safety, environmental and quality practices and procedures as outlines in organizational/departmental guidelines and SOPs as well as applicable, federal, state and local regulations.

Qualifications:

Must have Bachelors Degree from a four year college or University.