CHERRIL B. GANADEN

aduyik@r.postjobfree.com

Brentwood, Ca 94513

925-***-****

SUMMARY:

QA Documentation Specialist with experience in Documentation and Quality Assurance in FDA, GMP, GDP and GLP Environment and ISO13485.

Trained on Personnel Protective Equipment (PPE) for Laboratory. Fully gowned and have worked in a Clean Environment.

Managed and pulling materials in building the kit for production assembly.

Coordinated with the warehouse personnel for shipment of finished goods.

Maintained Quality Management System (QMS).

Data entry updated metrics/associated log and upload documents in the software application.

20 years experience in QA/Document Control in Medical Device/Pharma/Diagnostics Company.

Analyzes Engineering Change Order (ECO) Change Requests/Change Notice for completeness and accuracy.

Processed Document Change Request (DCR) and incorporate redlines from the Author and Reviewer for released. (Routed Electronically and Manually). Upload released pdf. Document in the database/software.

Updated minimal changes on Standard Operating Procedure (SOPs)

Reviewed and Processed documents for Released, including - Protocols, Reports, Standard Operating Procedures (SOP), Design History Record (DHR), Design History Files (DHF), Specifications, Quality Inspection Reports, Work Instructions, Methods of Analysis and Bill of Materials, Compilation of Test Cases in accordance with current Good Manufacturing Practices (cGMPs, GDP, GLP, GMP).

Maintain GxP Training Records.

Reviewed/compiled Master Batch Record (MBR) for released and for distribution.

Audited/reviewed and released production batch records of finished goods in a timely manner to support production schedule.

Coordinate with the Contract Manufacturing Organization (CMO)in terms of batch record release.

Experienced in supporting project–related and Quality Management System using Electronic Data Management System (EDMS).

Substantial experience coordinating, compiling, organizing, and preparing documentation packages for Device Master Records, Design History Files, and global regulatory submissions and registration packages.

Reviewed and maintained eCAD/Solidworks drawings for engineers.

Assisted in Internal and External Audit (Administrative Support)

Responsible for material released, kitting and line clearance for operation. Inspection and QA Lot Released.

Received and shipped out samples for clients.

Created, reviewed and released Certificate of Analysis (CoA), Certificate of Conformance (CoC).

Responsible in issuing and printing Master Batch Record (MBR) for Operations.

Responsible in preparing/generate, proofread and reconciliation of labels for operation.

Reviewed/verified and approved Labels, First Article Inspection, Manual Validation, using ETQ application.

Responsible in issuing part number, lot number and updated associated log/metrics.

Responsible for scheduling calibration equipment and maintained the database.

Maintained the QA-Documentation file room, scanning, filling current active and archived document(s), Protocols, Reports, Test Cases and Logbook/Notebook. Responsible for off-site and retrieval of documents.

Responsible in issuing/reviewing Lab Notebook, Logbook and updated associated log.

Managed new hire signature log and make folder for new employee.

Maintained and updated Training Records of the company employee(s) and updated Log Matrices.

Team player, detailed oriented person and attention to detail.

PROFESSIONAL EXPERIENCE:

Joinn Biologics (Full Time Employee)

Richmond, Ca

Document Control Supervisor Feb. 08, 2021 to Present

Manage document control department. Manage the workflow in processing the document for new and revise document thru the Electronic Management System (EDMS) Syberworks.

Collaborate with the Author/Subject Matter Experts (SME) with their documents.

Editing and formatting MS Word document, Convert to Acrobat pdf.

Check in and check out of the documents for redlines from the author/owner.

Issuance of document number for Master Batch Record, processed and issue Batch Production Record for production use.

Manage/maintain GxP training of all employees. Update training binders and credit training curricula into the software.

Issue document number (Protocol, SOP’s, Reports, Validation, Batch Record, CoA, COT etc).

Issuance of Logbook and archival of the Logbook, update the excel tracker spreadsheet.

Issue box label in archiving documents for storage.

Responsible in uploading all relevant documents- Reports, Protocol, Validation documents,

Certificate of Analysis, Certificate of Testing, Standard Operating Procedure to the quality system software- (Syberworks)

Issue Document Change Request (DCR) analyze the changes and update the excel tracker.

Assist the Internal and External Audit (administrative support)

Rodan and Fields (Contract Position)

San Francisco Ca

Senior Quality and Product Release Specialist Sep. 2020 to Dec. 2020

Generate QA re-labeling protocols, QA documentation.

Monitor product expiration dates of existing retain stock and annual standards to ensure the highest standards of

product quality.

Work cross-functionally to assist/support the logistics team with reporting, transactions, and on time in full (OTIF) inventory builds to support product launch strategies.

Maintains the company’s product quality and Stability processes, perform document control activities and support Quality Management Systems

Assists with the archiving and storage of batch production, product re-labeling documentation and laboratory control records.

Help create, organize, manage, and archive cGMP documentation, product release, investigation support documents, non-conformance, CAPA.

Performs a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements.

Upload all relevant GMP reports to the quality system software (Veeva). Support deviation, change control, and other GMP document upload, review, and approval process with proper workflow in to the GMP eQMS system

Zoetis (Contract Position)

Union City, Ca

Document Control Specialist Mar 2020 to May 2020

Reviewed/Routed/Processed/Released Document Change Order (DCOs) manually routed to the approvers.

Uploaded released documents in the Q:drive, updated the Matrix log.

Printed Master Document.

Distribution of approved documents (Updated affected Binders) removed the old revision.

Responsible in issuing DCO (Document Control Order) number and update document log.

Issued document number, Reviewed and Maintained Quality documents (SOPs, Wok Instructions, Reports, Protocols)

Maintain controlled document locations and retrieval of obsolete documents. Scanned and upload multiple documents in the database. Issuance of Log Notebook and updated associated log.

Bio-Rad (Contract Position)

Richmond, Ca

Quality Assurance Specialist Dec 2018 to Nov 2019

Audited/reviewed and released production batch records of finished goods in a timely manner to support production schedule. (Support Hercules and Richmond facilities)

Processed QA lockdown requests for document(s) reviewed stamped and protect.

Processed Service Now Requests - unlocking document(s)

Unlink material number(s) from the approved DIR.

Obsolete document(s) and PRD flag purchasing relevant with an approved Engineering Record (ER)

Supported Hercules Facilities- Reviewed/verified and approved Labels, First Article Inspection, Manual Validation, using ETQ application. Reviewed batch record released for production, Archived documents for storage.

TriReme Medical (Full Time Employee)

Pleasanton, Ca

Document Control Specialist Jun 2018 to Sep 2018

Reviewed/Routed/Processed Document Change Order (DCO)/Engineering Change Order (ECO) and incorporate redlines from the owner for routing and released.

Print documents for Engineering group, Document filing, masters, copies and drafts within a current manual and an electronic change control system.

Reviewed and Maintained Quality documents. Scanned and upload documents in the database.

Distribution of approved documents.

Maintain controlled document locations and retrieval of obsolete documents.

Maintain external standards library including ordering and tracking through internet based standards tracking service.

Maintain supplier files and key supplier list.

Maintenance of Training Records and update training log matrix.

Maintenance of Device History Records as required. Review lot history records and release finished goods.

Complete Certificates of Analysis and Conformance as required.

Compilation of documents and make folders/binders.

Boehringer Ingelheim (Contract Position)

Fremont, Ca

Document Control Specialist Jul 2017 to Apr 2018

Paper batch record authoring/revision/template creation and responsible in monitoring of document revision workflows. Checking out and checking in for redlines and update of the revised document.

Fill out/create electronic form for submission of Change Request (CR) for revision in the electronic document control system.

Update the spreadsheet/document tracker of Change Control that was being submitted and completed.

Responsible in checking out, checking in and upload document with redlines in the document control system.

In corporate redlines, formatting/editing MS word document for SOP revision from the author.

Follow-up/coordinate with the owner, approver and reviewer for document revisions.

Monitor the workflow of the document for revision in the database.

Responsible in checking the status of CAPA thru SAP.

PCT Caladrius (Contract Position)

Moutain View, Ca

QA Associate II Oct 2016 – Jul 2017

Responsible in issuing and printing Master Batch Record for operation. Upload new released/revision document into the database and send notification.

Review Master Batch Record/Executed Batch Record from Operation in accordance with cGMP and GDP.

Responsible for material released, kitting and line clearance for operation. QA Lot Released.

Responsible in preparing/generate, proofread and reconciliation of labels for operation.

Responsible for issuing Deviation Investigation Report (DIR) and Change Notice (CN) number and Due Date, follow up the status of the DIR, and update associated log.

Going in inside the clean room to verify status of equipments for calibration and must be in fully gowned.

Managed and pulling up materials to build up the kit for production.

Dermira (Contract Position)

Menlo Park, CA

QA/Document Control Specialist Apr 2016 – Aug 2016

Manage all aspect of client’s GxP training program including the distribution of training records, filing of completed records, oversight of training compliance, and periodic auditing of training records.

Maintain GxP related quality system master and historical SOPs including routing of new and revised procedures according to established timelines, editing of documents based on stakeholder feedback, management of effective and obsolete records.

Document control including Engineering Change Notifications, new part process, revision control, Change Request/Master Documentation Log.

Managed/conduct internal quality audits on document management related processes and procedures.

Manage incoming external documentation from CROs and CMO including of master batch files and executed batch files, raw data, method validation protocols and reports, stability and release testing data, study protocols and reports, specifications, and other controlled documents as required.

Fresenius Medical Care (Contract Position)

Concord, CA

Document Control Specialist Jul 2015 - Mar 2016

Processed Document Change Order (DCO) and incorporate redlines from the owner for routing and released. Maintained the workflow of the revised document.

Reviewed and Processed documents, including: Protocols, Reports, Standard Operating Procedures, Work Instruction, in accordance with current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDP). Assisted Internal and External Audit (Administrative Support)

Maintained Device Master Record and Device History Records as part of the quality system, and maintain department databases. Responsible in issuing document number and update document log.

Processed (review, track, copy, scan, file, archive and maintain) quality documents and records in electronic and hardcopy format per relevant procedures. Upload released documents and quality records in Windchill,

Maintained Document Control room, filling, make labels for the new document. Retrieved document record from storage.

Silk Road Medical (Full Time Employee)

Sunnyvale, CA

Document Control Specialist Mar 2014 - Jul 2015

Processed (review, track, copy, scan, file, archive and maintain) quality documents and records in electronic and hardcopy format per relevant procedures. Reviewed Lot History Record (LHR) document.

Analyzes Change Requests (CRs) for completeness, responsible and maintained the workflow of the document for revision.

Processed Engineering Change Order (ECO) assigned and route for signature approval.

Editing and formatting MS Word document, Convert to Acrobat pdf.

Issued Document Change Order, Document, Advertisement & Promotional number.

Issue Lab Notebook and Control engineering lab notebook distribution and retrieval.

Track employee training requirements and maintain employee training files, trending matrix every month.

Audit quality records (e.g. device history records, equipment records) for completeness, accuracy, and conformance to appropriate SOP’s.

Upload released documents in the Hyperlink.

Experience with data entry and maintenance of training records, maintenance of CMO log and preparation of files for transfer.

Maintained/Update document log and matrix. Perform other duties as assigned.

Assisted FDA submission (Coordinate printing, assembly, and bindery of hard-copy regulatory submissions, proof hard-copies against standard checklists from Regulatory Operations. Layout custom tabs for hard-copy printouts, labels for CD-ROMs. Create final CD-ROMs for electronic submissions, and proof against standard checklists.

DSM Biomedical (Full Time Employee)

Berkeley, CA

QA Specialist Feb 2013 - Dec 2013

Reviewed and approved production batch records, analytical test records for product/raw material released.

Reviewed and Processed documents, including: Protocols, Reports, Standard Operating Procedures, Specifications, Quality Inspection Reports, Work Instructions, Methods of Analysis and Bill of Materials, in accordance with current Good Manufacturing Practices (cGMPs) Created, reviewed and released Certificate of Analysis (CoA).

Reviewed, approved and assigned CAPA, DIR number and due date (Deviation Investigation Report) coordinate with the owner, closed and updated CAPA and Deviation log.

Reviewed and Processed documents, including: Protocols, Reports, Standard Operating Procedures (SOP), Specifications, Interacted with vendors to obtain technical information and Certificates of Analysis.

Prepared/Generate, proofread and reconciliation of labels and barcode for production for reject on-hold and tagged raw materials.

Novo Nordisk (Full Time Employee)

Hayward, CA

QA/Documentation Specialist III May 2008 - Feb 2013

Reviewed and Processed documents, including: Protocols, Reports, Standard Operating Procedures, Specifications,

Quality Inspection Reports, Work Instructions, Methods of Analysis and Bill of Materials, in accordance with current Good Manufacturing Practices (cGMPs) and Good Documentation Practices (GDP).

Creates and maintains project records for Device History Records (DHR), Design History Files (DHF), and Device Master Records (DMR).

Processed incoming document packages at check-in for initial review for correctness, acknowledgment to initiator and disposition of package. Processed Change Request.

Responsible for issuing Deviation Investigation Report (DIR) number and Due Date, follow up the status of the DIR, and update associated logs.

Editing and formatting MS Word document. Convert to Acrobat pdf., Scanning of document.

Maintained records and logs regarding the location and disposition of documents at on and offsite locations.

Issued and maintained log of Laboratory and Equipments notebooks.

Maintained the QA-Documentation file room, filling current active, and archived files, Protocols, Reports and Logbook/Notebook.

Microgenics Corp. (Full Time Employee)

Fremont, CA

QA Documentation Batch Record Reviewer II Nov 2000 - Apr 2008

Audited/reviewed and released production batch records in a timely manner to support production schedule.

Responsible in issuing/organized and print Master Batch Record.

Responsible/Maintained for issuing Deviation Investigation Report, CAPA number and due date, follow up the status of the DIR, CAPA from the owner, review the form thru GDP and updated CAPA and Deviation tracker.

Reviewed all documents to make sure the information is correct, in accordance with current Good Manufacturing Practices (cGMPs). Assisted Internal and External audit.

Formatting/editing MS word document, Convert Acrobat to pdf.

Substantial experience coordinating, compiling, organizing, and preparing documentation packages for Device Master Records, Design History Files, and global regulatory submissions and registration packages.

Coordinated with Planners, Manufacturing Manager, QA and QC Manager on daily activities. Followed up on discrepancy and error in real time.

Assisted customer with their documents in the QA-controlled room, or e-mail request.

Routed Procedure Change Request for signatures, Ran delinquent Procedure Change Order report.

Responsible for scanning the Certificate of Analysis for the release of the product.

Filed and organized documents in the QA-controlled room and generate labels. Archived/and or Retrieved document records for storage. Updated the controlled binders.

Managed new hire signature log and make folder for new employee.

TECHNICAL SKILLS:

Proficient in Microsoft Office, Excel, MS Word, Windows Explorer, Outlook, Lotus, Acrobat Reader (pdf), Accounting Peachtree, Synergestic, QA Application, File Maker Pro, Document Control System, NetDocs., Dia Docs., SAP, Master Control, Trackwise, Share Point, Veeva Vault, My Label Deluxe Designer, GMP Print Labels, Windows 7, LIMS, SysPro, Enterprise Resource Planning (ERP), Master Control System, Electronic Data Management System (EDMS), IDEA for CON, LiveLink/Hyperlink, Windchill, QT9 Electronic Quality Management System (EQMS), Netsuite, IDEA For CON, ETQ, Syberworks

EDUCATION: Union Christian College, San Fernando, La Union, Philippines

-Bachelor of Science in Commerce - Major in Banking and Finance (Philippines)

-Associate in Secretarial Science (2 years degree - Philippines)

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