Sonya Ridenour Email & Phone Number

Remote

Morgantown, West Virginia, United States

Oversee the Quality Learning and Development departments which are responsible for all quality training curricula including, but not limited to, the following departments: Quality Control Lab, Quality Assurance Operations and Lab, Review and Release, Investigations/CAPA/Complaint, Batch Issuance, Quality Executives, and Change Control. Create and/or approve GxP training programs, new employee orientation training, site wide learnings, and training for CAPA driven changes. Report departmental metrics, continue to lead improvement efforts throughout the site, and provide support during/after health authority inspections.

Morgantown, Wv

Act as a liaison between both manufacturing operations and quality departments to ensure training programs were adequate and make improvements where necessary. Continued to support various continuous improvement efforts throughout all departments. Provide support during Health Authority inspections by fielding and categorizing document requests, acting as a scribe during audits, and being interviewed as a subject matter expert when appropriate.

Oversee the dry granulation department, which includes blending, milling, and compaction areas. Supervise approximately 55 bargaining unit employees and 4 salary area leads. Perform/oversee daily departmental activities including but not limited to scheduling, process review, deviation investigations, KRONOS time keeping, safety incident coverage, training, and metric tracking. Led and supported several continuous improvement projects.

Morgantown Wv

Investigate deviations that occur during the manufacturing of generic pharmaceuticals to determine the final disposition of material and commercial viability. Review and Edit current Standard Operating Procedures as needed to prevent any future deviations. Review Master Formula Records and verify that they are compliant to current industry standards. Initiate and close CAPAs with Effectiveness Checks.

Quality Control analyst performing assay, related compounds, residual solvent, and uniformity testing for raw materials and finished products. Develop and validate HPLC, UPLC, and GC methods. Trained on ICP/MS to perform elemental impurity testing as per ICH guidelines. Author validation and development reports and notes. Main objectives included Corrective/Preventative Actions and lead continuous improvement efforts within the QC lab.

Master Of Science (Ms), Biotechnology

Bachelor Of Science (Bs), Biology, General