Marcus Roberts Email & Phone Number

South San Francisco, California, Us

Responsible for supporting development and implementation of the Quality Management System (QMS) and supporting infrastructure/tools in compliance with International Standards Organization (ISO) regulations, FDA Quality System Regulation (QSR), and corporate requirements. Manage CAPAs, Non-conformances, Internal Audit Findings, and Customer Complaints in QMS system. Updated and improved QMS system for tracking and trending (KPIs) as well as improved the flow of Quality record investigations. Supported administration of Management Review process such as gathering and establishing Quality Management System requirements and metrics.Actively participate in customer/regulatory authority audit preparation efforts by supporting planning, gap analysis, and mitigation implementation activities required to comply with new regulation and standards.Created audit readiness program which has led to over 15 successful external audits as well as regulatory audits and transfers of ISO-13485 certifications.Managed External and Internal Complaint System.

Cambridge, Cambridgeshire, Gb

Business Process Owner for Quality Learning Management and Document Management system. Responsible for the delivery of SABA Cloud and AZ Doc systems to AstraZeneca Redwood City. Developing, improving, and delivering learning management program and document management processing to find GAPs and mitigate risk. Proficient in performing risk analyst and level zero assessments to ensure that processes are compliant with AZ ways of working. Responsible to perform compliance GAP assessments and risk assessment to Quality Control Manuals that govern quality systems, Site Master File, and audit preparation.Subject Matter Expert in a fast paced pharmaceutical environment.

New York, New York, Us

Support Clinical System Manager with the system audits of 19 active clinical studies. Assist manger in collecting document for inspection in clinical trial database. Perform quality check and analyst pertaining to closed studies in clinical trial database. Collaborate with various teams such as Clinical Operations, Clinical Trials, and Drug Safety to complete reconciliation of all active and non-active studies. Cross reference document repositories against index to identify gaps. Review and evaluate all system documents that pertain to reconciliation project such as UAT, System Enhancements, Data Transfers, IRT System requirements, and Randomizations documents. Assist with the validation process, by contacting vendors to obtain missing documents to reconcile studies in system audit. Working closely with vendors such as Almac, End Point, and Bracket to obtain all system documents.

South San Francisco, California, Us

Assist manager with extraction of data/compiled all data into spreadsheets. Effectively extract all data from inexact match reports/ upload all data into Genentech database.Follow all Document Retention process with electronic documents and physical files. Complete drug safety monitoring and tracking in a timely, thorough and accurate manner in accordance with pharmacovigilance standards, regulations and Genentech/Roche Standard Operating Procedures (SOPs) and (SAEs).Assist in a group of 10 people in a special project: MHRA CAPA (CAPA22k) under the direction of the US Drug Safety. Intermediate use, training and navigation of databases. Enhance modify and create extraction procedures of the Case Management System (Sales-force) and database systems such as Single-Point of Contact.Review multiple cases containing HIPPA information. Ensuring each report managed matches the patients’ information given.Responsible for the organization, tracking and archiving of individual case safety reports, and other US Drug Safety associated documents, and participation in the production of associated supportive documentation.Follows all laws, FDA regulations and policies that govern the conduct of all activities. Accountable for being fully knowledgeable and adherent of all relevant policies.

South San Francisco, California, Us

Provide consistent customer focused reimbursement support to patients, distributors, and physician offices, resulting in expansion of customer referrals in the territory, both new and conversion referrals.Provide customers with education and assistance to navigate easily through the reimbursement process and on-line portal.Regularly identify barriers to patient access to treatment and continually identify and recommend program efficiencies to Leadership and external groups such as Field Managed Care and Sales.Establish strong relationships with Field Partners, MD offices, pharmacy partners and fellow coworkers. Conduct medical benefits, coverage and payer research/investigations to ensure appropriate resources, compliance with payer appeal and policies that pertains to general medical benefit practices within compliance timelines. Manage all steps, timing and outcomes during appeal process. Including completing written communications to patients and other external parties on appeal progress in a metric-driven environment.

Los Angeles, Ca, Us

Developed applicant forms and brochures for various units by researching and updating information as needed as well as edited materials for conferences, lectures, and seminarsAssisted with planning all guest lectures visits and accommodations Responsible for generating monthly reports and budgets for Bunche Center Attended weekly construction meetings; prepared, distributed and obtained approval of team meeting minutes.Extensive knowledge of web based documents control system which was used to post and log all projects for committees review and approval for project budgets. Program policy and procedure development

Los Angeles, Ca, Us

Responsible for maintaining compliance with federal regulations pertaining to Financial Aid GuidelinesManaged database systems in compliance with University protocol.Organized and scanned classified documents in accordance with FASFA regulations Conducted research projects to assist department leadership in identifying fraudulent documents and errors within student documentation. Supported manager with daily report preparation and used database to log, upload, and track documentResponsible for uploading electronic student documentation to the University and Federal Student Aid Office.

Managed a caseload of 15-25 clients.Provided support, referrals and advocacy for mental health conditions such as drug and alcohol abuse, mood disorders, depression, and psychosis disorder.Responsible for scheduling client medical appointments.Used active listening and other counseling skill sets to establish rapport, assess client emotional state and communication style, as well as to determine the unique needs of clients.Prepared nightly client interaction summary reports.

Bachelor Of Arts (B.A.), African-American/Black Studies

Intercultural Communication, Communication, General