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 part 211. Reviews COAs and CORs for incoming material.-Writes and revises SOPs and work instructions for continuous improvement.-Provides quality support to manufacturing by performing process observations to assure the use of aseptic technique. Escalates processing issues and product impacting quality events to area management.

-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 suppliers.-Routinely reviewed environmental monitoring data for ISO classified clean rooms.-Supported the review of risk management documentation for medical devices such as risk management reports and risk analysis.-Supported quality systems that scheduled and tracked the completion of post-market surveillance and risk management activities for various medical devices.-Participated in collecting data for metrics presented in quarterly management review meetings.

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 documented investigations of quality events through nonconformances and deviations.-Completed internal audits at various Havpak facilities and communicated 21 CFR 820 compliance gaps to area management.-Completed mock recalls as required by customers.-Prepared for and participated in external quality audits.

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.