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RAY ZAKEYA S
- 1. Z A KE Y A S . R A Y (919) 436.5346 ms.ray0721@gmail.com S U M M A R Y Adaptable and independent team player with extensive experience in documentation control coordination, with a solid background in data management for quality control and clinical research groups, including technical writing, editing, and formatting skills. Knowledge of all stages of lifecycle documentation related, but not limited to, SOPs, material specifications, work instruction, validation protocols, and journals. Highly proficient in executing document change controls, utilizing Documentum, MasterControl, TrackWise, GXPharma, DocuShare, SharePoint, CoreDossier, and ISIToolBox. Major contributor in meeting consent decree requirements, maintaining documents and training records for FDA inspection readiness in accordance with GMP and ISO 9000 guidelines. Highly personable and detail-oriented collaborator with the ability to meet operational deadlines in a timely manner. E X P E R I E N C E PFIZER (Formerly Hospira), Rocky Mount, North Carolina Chemical Quality (CQ) Lab Document Control Specialist...........................................................................................2012-2016 • Served as liaison to CQ Lab within manufacturing facility on creating, revising, and obsolescing GMP procedures/documents (SOPs, batch records, CAPAs, and change controls) • Managed all stages of lifecycle documentation (review, approval, issuance, and distribution), using validated GMP electronic systems, including rDocs, SAP, and AS/400, to meet deadlines • Assisted in assembling batch records when needed • Expedited APQRs (annual product quality reviews) • Supported data review (locating logbooks/notebooks, making copies, entering information in LIMS, and assembling QA packages) when needed • Aided in approval of reconciled controlled drug documents • Searched various internal databases for documents needed to support change requests • Compiled required documentation for each individual change request • Reconciled change requests for initiation to closure • Collaborated with Investigations department to close audited cited issues within deadlines • Reviewed and approved engineering validation instrumentation packages DISCOVERY LABORATORIES, Totowa, New Jersey Document Control Coordinator (Scientific Search Staffing)........................................................................................2010-2011 • Served as liaison to Manufacturing and Quality Operations (QO) on creating, revising, and obsolescing procedures • Managed all stages of lifecycle documentation (review, approval, issuance, and distribution), using manual change control system • Maintained manual and electronic library of all GMP documents (SOPs, MBRs, INVs, non-conformances, CAPAs, and change controls) • Performed reconciliation and record retention of change control documents requiring archiving • Managed issuance and reconciliation of controlled documents (datasheets, logbooks, and change control forms) • Provided daily reports to Manufacturing and QO on status of documents made effective, revised, or obsolete • Processed and maintained training records, performing gap analysis to ensure compliance • Prepared training packages and curricula for affected departments, coordinating meetings
- 2. Zakeya S. Ray,Page 2 C. R. BARD, INC., New Providence, New Jersey Document Control Coordinator (Execu|Search).....................................................................................................................2010 • Served as liaison to QO, managing creation, revision, and obsolescence of documents • Managed all stages of lifecycle documentation (review, approval, issuance, and distribution) for SOPs, using DocuShare • Utilized electronic management system (MasterControl) to maintain library of all GMP documents (SOPs, MBRs, INVs, non-conformances, CAPAs, and change controls) • Performed reconciliation and record retention of change control documents requiring archiving • Provided weekly updates to Manufacturing and QO on status of documents made effective, revised, or obsolete MUSCULOSKELETAL TRANSPLANT FOUNDATION, Edison, New Jersey Document Control Specialist (Kelly Services)..........................................................................................................................2009 • Served as liaison to various pharmaceutical groups to ensure efficient management of all documentation • Managed all stages of lifecycle documentation of SOPs, work instructions, forms, flow charts, raw material specifications, and calibration documents • Performed gap analysis of documents to ensure biennial requirements achieved and training records current • Utilized electronic management system (MasterControl) to maintain library of all GMP documents (SOPs, MBRs, INVs, non-conformances, CAPAs, and change controls) JOHNSON & JOHNSON (TIBOTEC), Bridgewater, New Jersey Medical Information Operations Specialist (Kelly Services)........................................................................................2008-2009 • Ensured all incoming fax inquiries processed and entered into medical information database • Performed accurate MIR data entry into MasterControl • Processed batch record printouts on daily basis, assembling and delivering complete response packets to Medical Information Specialist for approval • Assisted Switchboard Operators in forwarding incoming calls to respective departments as needed • Managed interdepartmental medical information box inquiries as well as outside requests via Internet • Maintained lifecycle of inquiries, published document files, and ordered published literature as requested • Created and edited citations and enclosures for all publications, including posters, oral presentations, abstracts, etc. as requested • Maintained data of literature and trained QA personnel on system use and functionality • Reported PQCs in accordance with department SOPs, providing input for work processes to maintain compliance • Managed and compiled business card emailed responses JOHNSON & JOHNSON (PRD), Raritan, New Jersey Senior Clinical Data Coordinator (Challenging Training & Consultant)...................................................................2007-2008 • Liaised with Document Specialist and Medical Writers for compilation of submission documents (protocols, study reports, sample case report forms (CRFs), sample consent forms, investigator/IRB/IEC list, and investigator CVs) • Processed document components through Documentum-based submission repository • Edited scanned documents by linking virtual documents (VDs), reviewing for completion, and processing for approval • Assisted Clinical Trial Associates in creating and modifying CVs and literature VDs • Processed imported documents and prepared scan request forms to ensure documents ready for submission • Verified journal articles entered in GRIPS database (Documentum), created no-content placeholders, and completed attributes • Managed transfer of documents in GRIPS and external eRoom, uploading all drafts
- 3. Zakeya S. Ray,Page 3 • Requested new articles from library, searching for LMD Global info and journal articles via Internet SANOFI-AVENTIS, Bridgewater, New Jersey Executive Administrative Assistant (Angelord Inc.)......................................................................................................2006-2007 • Coordinated, prepared, reviewed, and distributed all non-clinical and clinical DSE (drug safety evaluation) study reports and ancillary documents • Liaised with MPK and Quality Control as well as contract facilities for preparation of collaborative reports • Performed retrieval of documents from various databases as needed SCHERING-PLOUGH CORPORATION, Kenilworth, New Jersey Documentation System Administrator............................................................................................................................2000-2006 • Managed all stages of lifecycle documentation of SOPs, calibration documents, and/or test procedures for all pharmaceutical personnel, using document management system, Commandr • Coordinated with various departments to ensure timeliness of route and control of documents throughout lifecycle stages • Performed gap analysis of lifecycle documents to ensure compliance, issuing reports to respective departments • Assisted with implementation of newly installed electronic document change control system (Commandr) • Implemented training course on lifecycle documentation (issuance, route, review, and approval) for pharmaceutical personnel, including 500+ employees and new recruits • Assisted in validation and rollout mission for new version of Documentum • Created, coordinated, and maintained Documentation department’s intranet webpage • Prepared and processed grant payments and letters for outside vendors, maintaining copied documents for tracking purposes MERCK & CO., Rahway, New Jersey System Administrator (Kelly Services)...........................................................................................................................1998-2000 • Managed all stages of lifecycle documentation of SOPs, calibration documents, and/or test procedures for all pharmaceutical personnel, using Documentum data management system • Scheduled and attended weekly meetings, as well as processed expense vouchers, grants, and memos • Assisted with implementation of new MRL Grant and Consultant system • Created, prepared, and processed monthly budget, expense reports, and grant tie-out sheets E D U C A T I O N MILLER MOTTE COLLEGE, Raleigh, North Carolina, Core Classes toward AAS. in Medical Assistant, 2018 RAHWAY HIGH SCHOOL, Rahway, New Jersey, High School Diploma, 1994 S K I L L S / C E R T I F I C A T I O N TrackWise; LIMS; Documentum; VITEK; MicroSeq; Microsoft Office 2007, XP Certified Controlled Drug Agent (CDA)