Quality Manager

Janet Bumbarger

Quality Assurance

Expertise and Skills:

 CAPA Management

 Disposition of non-conforming materials

 Review/approval of non-standard processing

 Lead internal Auditor

 Document Control

 Change Order Management

 Clinical Trial Study Monitor

 Customer Trainer

 In-depth Knowledge of ISO 13485:2003 and 21 CFR Part 820

 Proficient in Pilgrim SmartSolve Software

EXPERIENCE:

Celerus Diagnostics, Inc. Carpinteria, CA 7/2008 – present

QA Manager

• Implementation of an ISO 13845:2003 and CFR 820 Compliant Quality System

• Full support of all Quality Functions

• Training of all personnel with respect to Quality

• Regulatory responsibility for Medical Devices products

Dako North America, Inc. Carpinteria, CA 9/2007 – 7/2008

QA Complaints Coordinator

• Review and assessment of all incoming complaints

• Facilitate and monitor complaint investigations and final closure of complaints

• Responsible for weekly, monthly, quarterly reports to management

• Internal Lead Auditor

Osmetech Molecular Diagnostics* Pasadena, CA 8/2000 – 9/2007

* Formerly Motorola Life Sciences and Clinical Micro Sensors

Quality Systems Specialist (7/05 – present)

Quality Assurance Supervisor (4/04 – 7/05),

Quality Assurance Specialist III (8/00 – 4/04),

Responsibilites Include:

• Configuration, Implementation, and facilitation of an electronic document management and CAPA/Complaints tracking system (SmartSolve by Pilgrim).

• Quality Metrics: monitor CAPAs (facilitation of the CAPA review board, improved the CAPA process, trained companywide, support failure analysis), audits, process deviations and non-conforming materials and perform trending of quality metrics.

• Record review with QA approval authority for: quality documents, nonconforming materials, process deviations, device history records, batch records, quality control data, supplier qualification, calibration and process logs, validation and verification study files, corrective actions, and audit reports. Alternate for departmental level responsibility and authority.

• Internal auditor: Lead auditor for internal and supplier quality audits, including preparation, investigation, reporting and follow-up to ensure compliance to the system requirements.

• Support of design control process, including, committee activities, record keeping and review, maintenance of Design History Files, and audits for compliance to requirements.

• Training: Perform Quality System and Regulatory training for all groups as required, and support the maintenance of training records.

• Customer trainer for CMS platform technology and assays. Developed training program, trained team of 6 laboratory and QA staff.

• Clinical Monitor for Clinical Trials conducted by CMS.

Quest Diagnostics Inc. San Juan Capistrano, CA 11/98 – 8/2000

Lab Associate II (8/99 – 8/2000), Molecular Genetics Department

• Part of a team responsible for the sequencing based HIV genotyping assay for drug resistance. Involved with all aspects of the assay from viral RNA extraction to data analysis. Automated sequencing using ABI 377 sequencers. Also responsible for training new personnel working on the assay, integration of new automated technologies.

Research Associate II (11/98 – 8/99), R&D Department

• Responsible for the development and optimization of new assays for the molecular genetics department using such techniques as: multiplex PCR reactions, dot blots, hybridizations, and chemiluminescent detection while following ISO 9001 laboratory regulations. Additional responsibilities include purchasing and ordering for the lab as well as maintenance and record keeping for pipettes and laboratory equipment.

Axys Pharmaceuticals (Formerly Sequana Therapeutics) La Jolla, CA 4/97 – 11/98

Associate Scientist II (4/98 – 11/98), Sequencing Department

• Responsibilities included : design of oligos and testing PCR strategies for reseqencing genes of interest. Carrying out sequencing and mutation detection based experiments. Sequence analysis using Mac based software such as ABI Sequence Analysis, Auto Assembler, Sequence Navigator and Factura. Worked under GLP conditions to receive patient samples, extract DNA, quanitiate DNA, perform TaqMan assays, analyze data and generate individual genotypes for pharmacogenomic clinical studies conducted at Axys Pharmaceuticals.

Associate Scientist II (12/97 – 4/98), Pharmacogenomics Department

• Resonsibilities included: sample collection, management and data entry, non-microsatellite genotyping, RFLP genotyping, and high-throughput automated DNA sequencing.

Associate Scientist I (8/97 – 12/97) Pharmacogenomics Department

• Responibilities included: DNA extractions from human blood samples, DNA quanitiation, plate production and QC. Running 377 ABI sequencers.

Intern (4/97 – 8/97) Pharmacogenomics Department

• Responsibilities included: PCR, gel electrophoresis, loading of sequencing gels, and DNA extractions.

Point Loma Nazarene University Point Loma, CA 8/97 – 12/97

Teachers Assistant, Genetics Lab

• Assisted with and taught general genetic lab procedures and tutored students in genetics.

SAIC, Naval R&D Pier 302 San Diego, CA 5/96 – 12/96

Intern, Research Division

• Responsiblities included: care, maintenance, and training of dolphins and Beluga whales participating in research projects.

EDUCATION

Graduated 1997 Point Loma Nazarene University Point Loma, CA

• B.A., Biology

• Honors: Dean’s List (95-97), PLNU Scholarship- 96/97 school year, and Dean’s Scholarship ’97 Fall Semester.

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