Quality Assurance Manager

BRIDGET HAHN

San Leandro, CA

425-***-**** *******@*******.***

OBJECTIVE

To contribute my quality assurance expertise to help a progressive pharmaceutical company reach its goals and objectives.

SUMMARY

Quality Assurance professional with experience that includes the following:

cGMPs, GLPs, GTPs, GCPs, QSRs, EDMS, LIMS, ICH, and ISO; and PIP during manufacturing.

Authoring SOPs, protocols, test methods, specifications, CAPAs, and reports.

Controlling documents, reviewing batch records and analytical data, equipment validation, and FDA submissions.

Conducting vendor/supplier audits and internal audits; hosting customer audits and FDA and ISO inspections

Small molecule drug and biologic drug manufacturing including: injectables, stem cells and solid dosage forms.

Self-motivated, detail-oriented, and well-organized with good computer skills and an open-door policy to support QA.

Published author with exceptional interpersonal skills, collaboration skills, and internal and external staff-training skills.

WORK EXPERIENCE

Quality Assurance Manager 2015-March 2017

AllCells, LLC, Alameda, CA (Stem Cells)

Developed and maintained the quality management system using cGMPs and GTPs for Clinical Grade Bone Marrow and Leukapheresis Products.

Wrote, approved, and controlled SOPs and documents.

Set up and populated employee training files.

Continuously improved processes for production, shipping and receiving and bioservices.

Hosted customer and regulatory agency audits.

Obtained CLIA, tissue bank and other licenses.

Reviewed manufacturing batch records.

Validated laboratory equipment.

Quality Assurance Consultant 2013-2014

Stemedica, Evofem/Cosmoderm, Bioserv, and BTS Research, San Diego, CA (CMOs)

Performed line clearances for manufacturing following cGMPs.

Managed contract testing sites and sample chain of custody.

Reviewed stability and release data, labeling and storage of QC samples.

Reviewed and assembled finished batch records.

Wrote IQs and PQs for cleanrooms and maintained environmental monitoring data.

Investigated deviations, NCMRs, and CAPAs.

Quality Assurance Manager 2012-2013

Numira Biosciences, Bothell, WA (GLP Animal Facility)

Inspected GLP animal studies in relation to bone diseases.

Tracked test samples from receipt to testing.

Ensured compliance with AAALAC and animal welfare regulations.

Reviewed raw data, protocols and final reports.

Interacted with clients and hosted on site audits.

Wrote and maintained SOPs and the facility archive.

Performed equipment validation and filed training records.

Conducted facility audits of the vivarium, test article formulation, and histopathology labs.

Followed DEA regulations for controlled drugs and attended safety meetings.

QA/QC Laboratory Manager 2006-2011

HIV Trials Network, Seattle, WA (HIV Vaccines)

Audited the Endpoint Lab for regulatory and GLP compliance. Reported to management quarterly.

Performed quality assurance for the GLP HIV Endpoint Laboratory and the Lab Program Department.

Administered the EDMS system in conjunction with Duke University and NICD of South Africa.

The lab tested volunteer’s blood using ELISpot and Intracellular Cytokine Staining (ICS) tests.

Controlled all documents, paper and electronic, including study plans, SOPs, training records, validation documents, deviations and corrective actions; coordinated and hosted DAIDs (FDA for AIDS facilities) audits; easily and readily retrieved documents.

Senior Quality Assurance Specialist 2004-2005

Xcyte Therapies, Inc., Seattle, WA (Stem Cells)

Audited suppliers, contract manufacturers, internal departments, and wrote reports.

Provided direction and QA oversight to 3 other quality associates.

Reviewed in-process and final product labels.

Controlled and distributed released raw materials and finished products.

Reviewed FDA submissions for correctness before submitting.

Trained employees on SOPs and GMPs.

Class 10,000 gowning qualified.

Have good communication and computer skills with knowledge of Quality Regulations.

Quality Assurance Specialist II 2002-2004

Sonus Pharmaceuticals, Inc., Bothell, WA (Injectable Cancer Drugs)

Managed quality and compliance of CMOs.

Acted as PIP (Person in Plant) during manufacturing.

Distributed clinical supplies for breast cancer studies, and reviewed batch records.

Prepared Master Quality Agreements, and established QA metrics.

Reviewed protocols and reports and performed editing of all controlled documents.

Maintained, developed and revised test methods, specifications, labels and SOPs.

Received and released GMP raw materials, finished products, and clinical site drugs.

Served as head of the Material Review Board.

Quality Assurance Manager 1999-2001

Clear Medical, Bellevue, WA (Reprocessed Medical Devices)

Coordinated calibration of all instruments and test fixtures and reviewed drawings.

Assembled Device History Records for over 100 devices.

Applied risk management processes.

Wrote 20 510(K)s for reprocessed medical devices.

Developed test procedures and work instructions.

Maintained and controlled all documentation.

Trained employees on procedures and GMPs.

Quality Assurance/Quality Control Manager 1994-1998

Dendreon Corporation, Mountain View, CA (Stem Cells)

Developed and started Provenge (Prostate cancer drug), which is now approved by the FDA.

Supported manufacturing and audited vendors and contractors.

Wrote and maintained documentation: SOPs, test methods, specifications, and batch records.

Implemented an Engineering Change Control system.

Approved final drugs and devices for use.

Wrote sections of INDs, NDAs, 510(K)s, and a Biological PMA and CMC sections of FDA submissions.

Trained employees on SOPs, and GMPs.

EDUCATION

B.S. Microbiology with a concentration in Environmental/Public Health

San Jose State University, San Jose, CA

REFERENCES

Available Upon Request.

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