Catherine C.

Batch Record Reviewer-QA Operations at VistaPharm, LLC
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Contact Information
us****@****om
(386) 825-5501
Location
Largo, Florida, United States, US

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Credentials

  • Total Quality Management- AMA
    American Management Association

Experience

  • VistaPharm, LLC
    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Batch Record Reviewer-QA Operations
      • Feb 2019 - Present

      • Performed review of manufacturing and packaging batch records. • Responsible for tracking, batch record, C of A, C of C review for release of CMO products.• Reviewed internal Material and Finished Product paperwork for CMO products.• Performed release of CMO products in ProcessPro.• Resolved any document discrepancies related to batch record review. • Responsible for creating, tracking and final review of company logbooks.• Created APR Lot List.• Performed issuance of Batch Records, Rework Instructions, Repack Instructions and Stability Forms.• Responsible for the following QA Trackers: Logbooks, Metrics, Raw Materials, Labeling and Document Control.• Performed Document control duties such as ensuring that only current documents are used and documents that have been superseded or obsolete versions were removed from QA drives and MasterControl.• Ensured formatting of documents was done correctly according to specifications.• Updated Master Control Binders and files. • Performed an internal audit of SOP binders used in Manufacturing.

  • Accupac
    • United States
    • Manufacturing
    • 100 - 200 Employee
    • Quality Assurance Associate
      • Feb 2018 - May 2019

      • Performed review of manufacturing and packaging batch records and performed release of customer products in LIMS and Accuterm.• Reviewed completed validation protocols and batch records for assurance that all activities were performed within compliance.• Resolved any document discrepancies related to batch record review, documentation and Quality assurance line audits• Handled the cataloging and storage of finished good retain samples.• Performed product quality retain evaluation for product quality complaints and annual product reviews.• Performed Quality Assurance line audits during manufacturing.

  • Meda in the US
    • Pharmaceutical Manufacturing
    • 100 - 200 Employee
    • Quality Assurance Specialist
      • Nov 2014 - Dec 2016

      Managed company product quality complaints. Managed change controls, non-conformance investigations, corrective and preventative actions and deviations using TrackWise database. Responsible for the document control of electronic documents and paper documents.

    • Supervisor of Quality Systems
      • Nov 2013 - Nov 2014

      Batch record review and Product release, Scheduled and conducted internal audits, Oversaw change control requests and monitor change control system, Managed customer complaint system, Assisted in the development and streamlining of on-going quality systems. Member of the Environmental Management Team, Quality Assurance Auditor, Quality Inspector and performed Environmental Monitoring.

    • Senior Quality Assurance Auditor
      • Nov 2003 - Nov 2013

      Responsible for the batch record review and disposition, Maintenance of the Quality Audit Program. Managed Product Quality Complaints. Responsible for review of stability and raw material analytical data. Responsible for quality metric reporting. Created training manuals for the QA Auditing Department.

  • VIVUS LLC
    • United States
    • Pharmaceutical Manufacturing
    • 1 - 100 Employee
    • Quality Assurance Auditor
      • Nov 1998 - Nov 2003

      Performed batch record review and review of analytical data, investigated discrepencies, followed up on corrective and preventitive actions. Trained new QA Auditors. Updated standard operating procedures. Created and implemented the use of logbooks and QA Auditor worksheets to improve tracking of batch records during the QA auditing review. Performed customer complaint handling and montored the Enviromental monitoring program.

    • Quality Assurance Line Inspector
      • Jul 1997 - Nov 1998

      Performed hourly QA line Inspections and testing during the coding, filling, bulk packaging and secondary packaging processess. Collected samples and maintained a database for QA retains. Performed enviromental monitoring and water sampling and documented results and investigated any OOS results. Trained new QA line Inspectors in QA line inspection and enviromental monitoring.

Education

  • Brookdale Community College
    Associate of Arts and Sciences (A.A.S.), Medical Laboratory Technology
    1994 - 1997
  • Southern New Hampshire University
    Business Administration and Management, General, 3.8
    -
  • Monmouth University
    Bachelor of Applied Science - BASc, Clinical/Medical Laboratory Science/Research and Allied Professions
    -

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