Quality Assurance Management

Chris Zilich

206-***-**** *****.******@*****.*** www.linkedin.com/in/chrispzilich

Senior Quality Assurance Professional

Extensive expertise in change management, learning development, and other

quality systems such as: corrective and preventative action plans,

investigation reporting, and systems-based auditing. Accomplished expert in

the initiation of process improvement projects that define business

problems and develop compliant solutions. Experience ranges from a global

pharmaceutical giant and start-up to small cap biotechnology firms under

GxP regulatory environments. Proven track record of building collaborative

working relationships, built on trust and rapport, ensuring successful

cross-functional project teams.

Education

2014

MBA, Technology Management, University of Washington, Foster School of

Business, Kirkland, WA

1999

BS, Marine Biology and Aquaculture, Florida Institute of Technology,

Melbourne, FL

Professional Experience

Omeros Corporation, Seattle, WA

2013 - Present

QUALITY ASSURANCE ASSOCIATE (Contract Consultant)

Performed internal audits of QA and GCLP nonconformance documentation for

investigator compliance project. Also managed document control functions

and launched development of corporate quality systems workflows.

. Verified GCP CMC deviation log against source data and documentation.

. Verified QA CMO nonconformance logs against source data and

documentation.

. Authored SOPs and/or revisions for Quality Systems improvements as

needed for GMP.

Dendreon Corporation, Seattle, WA

2010 - 2012

SENIOR QUALITY ASSURANCE ASSOCIATE

Managed corporate change control process, and revised process for

efficiencies as needed.

. Assisted in creation of Rest of World change management workflow,

based on European Union medicine EMEA requirements.

. Tracked and trended performance metrics for major and multi-site

corporate change requests.

. Created change control review board procedure and requirements, as

well as performed both the scheduling and facilitation of board

meetings.

Seattle Cancer Care Alliance, Seattle, WA

2010

QUALITY ASSURANCE ASSOCIATE II

Implemented and maintained quality systems such as corrective and

preventative actions (CAPAs), deviations, investigations, audit files,

process records and laboratory data review.

. Oversaw the environmental monitoring program for the cellular therapy

laboratory. This included producing trending and quarterly reports for

site leadership.

. Assisted with successful process and systems regulatory audit of cord

blood donor bank and followed through with the closing report of the

audit activity.

Chris Zilich

*****.******@*****.*** Page 2

ZymoGenetics Incorporated, Seattle, WA

2008 - 2010

SENIOR QUALITY ASSURANCE ASSOCIATE

Subject matter expert for change control and deviation processes for

regulatory audits.

. Facilitated change control review board meetings.

. Executed internal process and system audits and followed through to

closure of activities.

. Processed, coordinated and tracked contract manufacturing

organizations' critical documents for ZymoGenetics client review

and/or change request processing from contract clientele.

Sterling Reference Laboratories, Tacoma, WA

2007 - 2008

SENIOR CERTIFYING SCIENTIST

Released final data of positive toxicology reports and answered technical

questions for clientele.

. Certified to act as subject matter expert in phone-based drug court

hearings, when judges required more information on a positive result

of a guilty party.

GlaxoSmithKline, Zebulon, NC

2001 - 2007

ASSISTANT QUALITY ASSURANCE SCIENTIST

Project leader for emerging cleaning qualifications with validation groups

that support Advair and Relenza production, as well as critical utilities.

. Qualified cleaning standard operating procedures (SOPs) for new

blending and filling equipment that supported Advair/Relenza

production.

. Developed an SOP with EMC Documentum which import validated data into

Statistica for graphical analysis of quarterly data, and trained

colleagues on executing this function.

. Trained to become LeanSigma Operational Excellence Advocate and did

active research on streamlining workflow, controlling cross-

contamination areas, and assisting with internal auditing of QC

laboratories.

. Key subject matter expert in the root cause analysis of problems

installing a low-pressure nitrogen regulator in a critical utility

system.

. Audited external vendors who supplied raw materials and packaging

materials for Advair production against applicable regulatory and

quality standards.

Apex Bioscience Incorporated, Research Triangle Park, NC

2001

PRODUCTION/PROCESS DEVELOPMENT ASSOCIATE

Responsible for cGMP production and cGLP process development of a

hemoglobin-based parenteral drug.

. Assisted in development studies such as viral clearance,

deoxygenation, and process optimization.

. Authored company SOPs pertaining to the operation of the Sartochek 3

automated filter integrity tester.

Community Involvement

Co-organized "Team MOvenge", Dendreon's MOvember moustache fund-raising

team

Member of Dendreon Social Committee

Creator of "Bike and Grub Nights" for ZymoGenetics and Dendreon employees

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