Barbara S. Email & Phone Number

Redwood City, Ca, Us

Foster City, Ca, Us

Primary responsibilities include processing documents following defined processes/procedures§ Collaborates with customers to ensure changes are concise and complete§ Interacts with appropriate departments to establish priorities and deadlines for documents§ Understanding of systems used to support document processing

San Clemente, Ca, Us

Thousand Oaks, Ca, Us

The QA Document Specialist contract ended in June at Atara Bio. Currently, available for Fulltime or Contract job positions. Resume is attached to my LinkedIn profile. Worked with a dynamite QA Document team and Manager. Best Regards

Contractor Labeling Specialist● Agile PLM - updated and archive rebranded documents to be accessible for Regulatory/Translation dept. ● Adult and Child Hearing Aid Medical Device and associated products distributed worldwide.

Contractor Labeling Specialist● Windchill PLM process to release - new designed and rebranded Abbott device manufacture product labels.● Create new and edit existing product labels for CDs, pouches, boxes, Kraft boxes, and illustrated logo design for hardware products using Adobe Illustrator.● Ensure Part 820 Subpart D and Subpart K Labeling and Packaging Control Sec 820.120 were maintained procedures to control labelling activities.● Pacemakers and associated products distributed worldwide.

Contractor Documentation Specialist● Using Salesforce Propel PLM software Support the QA department to ensure company policies and document control and archiving processes conformed to cGMP and regulatory requirements. ● Assist with implementing the QMS for ISO 9001 certification.● Working knowledge of 21 CFR Part 820 QSR, specific for Medical Devices and ECOs.● Ensure Manufacturing travelers batch records conformed to Cytek processes. (Subpart L- Sec. 820.140, and Sec. 820.160)

Pasadena, California, Us

Contractor QA Document Control● Responsible to populate established batch record template with page count, file names and DS & DP reports● Ensure requested VeevaVault forms, and audit certificates, were expedited in a timely manner, and uploaded to Veeva Vault for process approval.● Ensure SOP’s, Drug Substances, Drug Product Documentation Binders identified and archived per Xencor standards and Quality Regulations (Sec. 820.5 Quality System Subpart D-Document Controls Sec.820.40)● Collaborate effectively with both QA teams in Monrovia and San Diego.

Mumbai, Maharashtra, In

Contractor Program Manager● Program Manager for a global medical supply company in Santa Ana, California, to coordinate recent acquired company post-production manufacturing documents to rebrand. Responsible to train the three-person offshore team, in Kolkata, India.● Collaborated with Santa Ana IT and Kolkata IT teams, to mirror key stakeholder’s laptop configurations to offshore users.● Ensured Manufacturing Change Order (MCO) were established to rebranding standard formats for over 4,000 documents.● Established a reference guide to detail the “action status” as part of the filename description for each document: (i.e., Rebranded, Redline, Roadblock, Redirected, Obsoleted.)● Due to weekly rebranding issues, a daily interactive team question and solution spreadsheet was implemented to share between time zones.● Implemented a daily Oracle Agile PLM training schedule for the first three months.● Challenges were resolved, as team India and Santa Ana became cohesive.

● Employee - Sr. Documentation Specialist● As part of the Quality organization (Tucson and Santa Clara), participated in preparing for notified body audits, internal desk and document review audits, supplier audits, license certifications, and instructed employees on Good Documentation Practices.● As a working graphic designer in the medical device/pharma field, my labelling experience applied to creating templates for instruction guides, (submitted for translations), Field service instructions, pamphlets and shipping instructions..● Selected to be part of the Labelling team for future projects. For example, a CE mark correction required 30 English manuals and associated 23 languages for each Instruction set to be PDF for review and approved.● As a team member we were instructed on how the medical device labelling system created final labels and track revisions.● Audit responsibilities included maintaining the equipment calibration records, reviewing the effectiveness of Agile process controls (DHR, BOMs, TD’s Development Documents). Prepared requests for initial review and process copies for the war room.● Initiated and setup the Document Control Vault to mirror corporate headquarters for Clinical, Regulatory, Imaging Lab slides, Batch records, Log Notebooks, Calibrated Equipment and binders.● Initiated and migrated 150 calibration equipment records to the Blue Mountain Regulatory Asset Manager (RAM)● Liaison Record Retention Coordinator, to provide instructions and training for bi-annual company-wide record disposal: paper documents, CDs, USB and damaged calibrated equipment.● Liaison Training Coordinator to ensure the organization’s training records were compliant and verified Team Managers● Collaborated with the regulatory team to prepare 510(k) original submissions. Retrieved historical supporting documentation to prepare final submission binders.

Document Control Specialist at BioImagene/Ventana Digital Pathology in Sunnyvale, CA.

Worked in Regulatory Affairs, to migrate 10,000+ files to be integrated and accessable using Documentum database.

Fort Worth, Texas, Us

● Created and edited manufacturing assembly instructions for the OmniScan bar code system, and Omnisurgical with photographs and videos for the field service team.● Experience with hardware technical writing and created many templates for a cohesive and branding print project● Initiated an e-source file for parts and equipment catalog, resulting in 30% service time reduction and eliminated unnecessary part order errors.● Interviewed Development engineers, to write OmniTips and OmniAlerts emails to implement product updates.● Initiated an installation service CD manual for the field service. CD source reduced carrying binders and ensured correct document revisions were ordered.

Plano, Tx, Us

Worked in Worldwide Sales to create Software Instructional/User Guide templates for CRM product line. Trained other consultants to use the templates and managed the extensive database of documents for all Worldwide software instructional guides.

As the sole owner of FineLine Graphics I designed company brand logos for graphic presentations, trade show displays and product packaging for companies in Silicon Valley.

Original pinball design [4x4] was selected for development. As a character animator, I created pixelated artwork (animation and background designs) for early successful coin-op games (Crystal Castle, Pole Position, Weather Wars, Indiana Jones). My animation drawings were selected to show at the Euphrat Gallery in SJ. The original title screen illustration for ('Liberator') was published in the "Great Computer Calendar". I loved the job, worked with a superb creative team, and Atari's Coin Op side of business was the best. After the years have past, I enjoy the smiling faces of kids playing Atari games.

Bachelor Of Arts - Ba, Technical Arts | Drafting | 3-D Art Sculptures

Certification, Electrical, Electronic And Communications Engineering Technology/Technician

Certification

Certification Program, Website Development

1.5 Year Program, Entrepreneurship/Entrepreneurial Studies