Chloe Devitis Email & Phone Number

Philadelphia, Pennsylvania, United States

-Performs risk assessments for deviations to determine the impact on safety and efficacy of finished product and processes.-Writes deviations and supports investigations for quality events.-Reviews master batch records to support the release of finished drug product.-Performs the receipt of materials and human tissue in accordance with 21 CFR part 1271 and.

-Conducted internal audits of various departments including quality control, manufacturing, product development and regulatory affairs against ISO 13485 and EU MDR requirements.-Wrote and distributed audit reports to area directors. -Supported supplier quality activities such as performing supplier audits and reviewed required documentation submitted by.

West Chester, Pennsylvania, United States

- Performed quality reviews of DHR and batch information as well as released finished product of class II medical devices.-Trained quality assurance personnel and routinely audited internal training credentials of facility employees.-Participated in the management of quality investigations regarding incoming materials from global suppliers. -Performed and.

Malvern, Pennsylvania, United States

-Performed quality reviews of QC lab documentation against test methods.-Performed in-process inspections on class I medical devices.-Participated in QC lab testing as well as coordinated sample submission for external lab testing.-Reviewed testing reports from external labs.-Reviewed COA documentation for incoming raw materials.