Helen Pierce Email and Phone Number

Support the GxP quality framework (polices, procedures, systems) under the guidance of the MSO Compliance Lead - Collect and analyze data for MSO metrics, including deviations, CAPA, and on-time-training - Manage document lifecycle from initiation to approval - Compile records for retention (Job Descriptions, CVs, Training Extensions, Organization Charts, etc)- Perform training assessments (appropriate training assignments, update of training documents) - Monitor Investigation, CAPA, Change Control, and Training for risks- Participate in internal audits and assessments

- Responsible for reportability assessment of potential health and safety complaints.- Collaborate with other groups such as engineering, clinical, regulatory, and marketing to ensure a thorough and accurate complaint investigation. - Provide leadership, coaching and mentoring to fellow colleagues responsible for workflow and training as Subject Matter Expert. - Recommend corrective actions related to complaint management process and procedures and monitors progress to ensure effectivity. - Collaborate with cross functional groups to drive process improvements and regulatory compliance. - Responsible for gathering, reporting and monitoring data for CHU quality metrics.- Participate and lead as CHU subject matter expert for regulatory inspections

-Evaluated and confirmed inquiries as product technical complaints-Reviewed completed investigations and coordinated with investigation sites to resolve discrepancies-Performed closeout of complaints

-Reviewed batch records from contract manufacturers and coordinate with suppliers to resolve discrepancies-Dispositioned clinical batches-Performed batch record reviews for complaint investigations-Maintained clinical labeling and procedures-Supported the change control process

-Investigated customer complaints and recommended corrective actions, when necessary-Generated and submited MDR, MDV, and Med Watch reports-Worked on cross-functional teams to represent QA Complaints -Revised and updated SOPs and Work Instructions

-Performed audits of LifeCell's human tissue suppliers to ensure compliance with FDA regulations and AATB standards. Follow up to ensure that audit findings are appropriately addressed through corrective and/or preventative actions-Coordinated responses to internal and regulatory audits and ensure corrective and preventative actions are completed within agreed upon timeframes-Coordinated recall activities and maintained records of communications with FDA, distributors, and customers-Revised and updated SOPs and forms