Lorraine Caputo Email & Phone Number

Caldwell, Nj, Us

Bethesda, Md, Us

• Develop and implement Quality Systems and associated Standard Operating Procedures• Lead investigations into consumer complaints and make recommendations for product improvements• Review and release products for commercial distribution• Manage stability and other quality testing programs• Address and drive to conclusion quality problems that arise• Conduct Quality Audits of manufacturing facilities• Manage projects involving changes to products and manufacturing processes

Bethesda, Md, Us

• Develop and implement Quality Systems and associated Standard Operating Procedures• Review key safety, clinical and regulatory documents• Lead investigations into consumer complaints and make recommendations for product improvements• Drive process improvement• Review and release products for commercial distribution• Address and drive to conclusion quality problems that arise• Conduct Quality Audits of manufacturing facilities

Slough, Berkshire, Gb

Apply risk management to the new product development process. Conduct cross audits of global RB R&D sites. Ensure inspection and audit readiness. Implement a fit for purpose Quality Management System. Site Lead for Quality Audits. Vendor Qualifications and audits. Plan and execute internal audit program. Quality approver for Change Controls and Deviations, and CAPAs.

• Manage the GXP controlled documentation system and associated records• Manage life-cycle of documents and related change control system• Facilitate communication and compliance with all cross-functional areas• Ensure timely revision of controlled documents• Oversee the change control program according to required protocols, procedures, and metrics• Administrator for GxP training (ComplianceWire) database• Develop and issue training reports (ComplianceWire) to support business needs and regulatory requests• Create training materials (power point slides, voice over, etc.)• Organize, schedule, and lead interactive training sessions, including biennial GMP training• Generate, compile and report Quality Metrics for training, documentation management, change control, and annual product reviews• Generate and revise SOPs to support Quality System requirements. Conduct periodic reviews of controlled documents• Participate and support external inspections of MDCO, including, inspection readiness activities, document/request delivery, audit facilitation/back room support. Track status of MDCO commitments to regulatory inspections, as assigned• Author Annual Product Reviews• Perform QC of regulatory and quality documents as needed

● Business process owner of global electronic learning management system.● Oversee the backroom during Regulatory Inspections● Monitor and report quality metrics for management review● Owner of the Annual Product Review Process

• Maintain, file, and track completion of MDCO quality assurance audit program (issue audit reports, track completion of audit commitments, file audit plans and corrective action plans, maintain GCP compliance files)• Track status of MDCO commitments to regulatory inspections• Maintain SOP training matrix for regulated MDCO areas (R&D, GPV, Supply Chain). Periodic reconciliation vs. roles and responsibilities assigned within teams. Act as a liaison between functional areas and training database administrator (xdoc)• Administrator for GCP training (Compliance Wire) database. Maintain other training content as needed• Perform Quality reviews in clinical development vs. quality plan• Review and oversight of maintenance and filing of trial master file (TMF) for various studies.• Periodic audits of TMF• Assist with internal/external GCP audits

Us

• Quality review and comparison to source data of Regulatory Agency submissions including Protocols and Amendments, ICFs, IBs, CSRs, IMPDs, Annual Reports, INDAs, DSURs, DMFs, and TMFs• Reviewed manufacturing, and labeling and packaging batch records• Released raw materials for manufacturing and product for distribution in Clinical Trials• Audited (internal and external) GMP, GLP, GCP operations• Maintained and updated SOPs• Reviewed and approved deviation reports and change controls• Developed the Document control system and executed its maintenance

Us

• Reviewed labeling and packaging, and performed release of raw materials, components, and drug product• Approved master and executed batch records• Inspected packaging job operations

• Provided service for 25 to 30 patients per day including administering injections, patient teaching, as well as staff training, corresponding with insurance companies for prior authorizations and overrides, and taking emergency phone calls after hours.

Morris Plains, New Jersey, Us

• Supervised the Quality Assurance Coordinator and Product Release Specialist• Managed the Document Control System under the regulations and requirements of 21 Code of Federal Regulations parts 210 and 211, Good Manufacturing Practices including staff training, releasing product and raw materials for clinical trials, developing/revising procedures, approving change controls and non conformance reports, auditing manufacturing operations, and preparing clinical trial shipments.

Salt Lake City, Ut, Us

• Worked under Good Manufacturing Practices Guidelines including reviewing and approving raw data and final reports for accuracy, completeness, and consistency, reviewing and maintaining SOPs, scheduling and maintaining ongoing preclinical/toxicology studies, and maintaining record retention policy, including scheduling and preparing records for internal and off-site archiving.

Bachelor'S Degree, Registered Nursing/Registered Nurse

Associate'S Degree, Registered Nursing/Registered Nurse

Associate Of Arts And Sciences (A.A.S.), Computer Systems Networking And Telecommunications