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Yyyyyy x. yyyyyy

0000 xxxxxx xxxx , xxxx , xxxxx 00000 ● 760-920-9866 ●


Seeking opportunity as Quality Assurance Specialist II

QA Documentation ~ QA Change Control ~ Records Management

Regulatory Compliance ~ Continuous Improvement ~ Inspections & Audits




         Consummate strengths in supporting quality, compliance, and documentation functions within biopharmaceutical manufacturing environments.

         Software proficiency includes EDMS, LiveLink, DocLink, TrackWise, FileNet, and Microsoft Office Suite (Word, Excel, Access).

         Well-versed in 5S approaches, OCP support, project coordination, change control process, and FDA requirements for GMP compliance.

         Adept at working with document control systems and delivering exemplary customer service.

         Proven ability to understand and communicate complex information, work in cross-disciplinary teams, and handle project tasks independently according to demanding schedules and budgets.

         Well-developed analytical, troubleshooting, research, reporting, and organizational skills


Selected Achievements


         Highly regarded for advanced technical expertise in EDMS and document controller tasks.

         Winner of multiple Applause Awards for exhibiting excellence in teamwork, customer service, and productivity.

         Consistently achieved and exceeded requirement achievement points specific to delivering fast and agile responses to demand changes .

         Shepherded QA documentation & scan operator teams during supervisor s three-month absence.

         Trained in Good Manufacturing Practices (GMP) and safety compliance within biopharmaceutical manufacturing settings.

         Contributed to process improvements including Green belt project, simplifying change control and document controller process at OCN, training new document controllers and scan operators, and L1 auto close process.

         Successfully transitioned records management expertise to other staff members in TCM by sharing information, effectively changing ownership of documents, and training scan operators.

         Received nearly 100% positive end-of-year (2016) feedback on multi-raters from customers for positive, open, and helpful attitude .


Professional Experience


Genentech, Inc, Oceanside, CA, 2006 to Present

Senior Documentation Specialist 2013 to Present

         Provide vital technical support to facilitate strict compliance with GMP activities and requirements of applicable Health Authorities.

         Ensure products consistently adhere to rigorous customer and regulatory requirements.

         Closely monitor, support, and coordinate technical change management of QA-controlled documents.

         Devise and manage department s QA Vault coverage schedule to ensure sufficient and seamless documentation support during Health Authority audits.

         Reliably support corporate financial goal attainment by ensuring purchases align with approved quality-driven process.


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Yyyyyy x. yyyyyy Page 2 of 2


         Schedule QA Vault Controlled Document Manual (CDM) quarterly audits and ensure Manufacturing s CDM audits are calendared within department.

         Consistently demonstrate steadfast flexibility in responding to requests for urgent change records.

         Spearhead average of 10+ TrackWise document change control assignments weekly.

         Train, mentor, coach, and support staff in software and processes encompassing Class A, 5S, FileNet/DSS, EDMS, and TrackWise.

         Streamline master file document maintenance, EDMS workflow processing, document change control, document releases, site quarterly CDM audits, and generation and dissemination of reports for EDMS DARs to site s document owners.

         Administer databases to track right first time , documentation routing, history, and reporting activities.

         Actively supported FileNet/DSS upgrade to expedite transition to new document imaging system.

         Collaboratively prepared and orchestrated cross-training plan for Strategic Workforce Planning roll-out.


Documentation Specialist 2006 to 2013

         Methodically provided influential quality documentation support to SIM Team for external and internal inspections.

         Supported OCP with clinical campaign documentation, processed commercial and clinical document changes in EDMS, maintained multiple databases, and diligently ensured constant compliance with GMP guidelines.

         Actively participated in cross-functional projects such as new technology roll-outs and high-impact process improvement initiatives.

         Established departmental practice to accurately track open EDMS DARs workflows to deliver information transparency and prevent discrepancies.

         Expeditiously processed CDM requests and change forms when submitted by CDM owners.

         Trained and mentored staff in software programs and company practices while promoting team cohesiveness and productivity.

         Served as backup presenter for QA documentation during inspections and as SIM team delegate.


Boston Scientific, Murrieta, CA, 2001 to 2006

Documentation Specialist II

         Retained full-time after temporary assignment in Customer Service department based on outstanding performance, and charged with maintaining and managing controlled documentation and departmental data for Director of Quality Assurance

         Orchestrated weekly change control board meetings to discuss change requests, and held crucial accountability for device master records.

         Revised, created, updated, and released controlled documentation records for finished devices and raw component lot history files according to ISO/FDA regulations.


EMCOR Service, Irvine, CA, 2000 to 2001

Administrative Assistant

         Performed full-scope administrative functions spanning work order preparation, dispatching assignments to technicians, maintaining office inventory, filing documents, and managing business correspondence.

         Efficiently operated multiple line telephone system, screened and routed incoming calls and messages, and greeted visitors.


County of Riverside, Department of Public Social Services, Temecula, CA, 1997 to 2000

Office Assistant III 1999 to 2000

         Promoted to assume supervisory position within Child Protective Services unit; trained staff, opened and assigned cases to social workers, and led research efforts via state and county database systems.


Office Assistant II 1997 to 1999

         Performed comprehensive research, assigned cases to eligibility technicians, maintained up-to-date office records, and prepared documents, spreadsheets, and graphs.


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