Sr. Manager, Document Management
Current
Apr 2024 - Present
AeroLeads people directory · profile
Christopher Fronek Email & Phone Number
Sr. Manager, Document Management
at
Omeros Corporation
1 work email found
@omeros.com
LinkedIn matched
✓ Verified August 2026
4 data sources
Profile completeness 100%
Current company
Role
Sr. Manager, Document Management
Location
Greater Seattle Area, United States
Who is Christopher Fronek? Overview
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Quick answer
Christopher Fronek is listed as Sr. Manager, Document Management at Omeros Corporation, based in Greater Seattle Area, United States. AeroLeads shows a work email signal at omeros.com and a matched LinkedIn profile for Christopher Fronek.
Christopher Fronek previously worked as Manager, Document Management at Omeros Corporation and Sr. Specialist, Document Management at Omeros Corporation. Christopher Fronek holds Masters, Comparative Literature from University Of Chicago.
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Email format at Omeros Corporation
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{first_initial}{last}@omeros.com
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Profile bio
About Christopher Fronek
Christopher Fronek is a Sr. Manager, Document Management at Omeros Corporation. He possess expertise in gmp, document management, quality assurance, quality system, sop and 11 more skills. Colleagues describe him as "As the former associate director of QA at IDB/GSK in Bothell, I can attest Chris was a pleasure to work with as one of our document control professionals. His understanding of the change systems involved in a regulated industry made my job easier, such as his development of a review tracker system to keep control of all our electronic and paper-based reviewer comments, which was out of control (pun intended) when I started. Chris was able to comprehend people’s ideas and get them down on paper regardless of their differing backgrounds and work with them, no matter how demanding the personalities, on building consensus for those particularly sticky documents. Chris is friendly, articulate and again was a great person to work with. I would highly recommend him to anyone currently looking for a document control professional. That or a trivia team member, he has amazing recall.", "Chris worked at Poniard Pharmaceuticals as a Document Control Specialist from Apr 2007 to Feb 2010 supporting GCP and GMP compliance oversight activities. Chris was responsible for management of internal change-controlled GCP and GMP documents, including SOPs, clincal study protocols, SOPs, specs, and labeling, as well as management of reference copies of third party documentation and translations. He also supported compilation of regulatory submissions. He has a solid understanding of the principles of document management and is sensitive to the balance between compliance requirements and user demands. He was an invaluable asset to me in implementing and improving quality systems, contributing constructive input and listening to users’ concerns. Chris is a seasoned, versatile worker and a pleasure to work with.", and "I highly recommend Chris, both professionally and personally. He is exceptionally knowledgeable about document control and is an absolute delight to work with. Chris is very sharp, and with his work ethic, would make an excellent hire for any company."
Listed skills include Gmp, Document Management, Quality Assurance, Quality System, and 12 others.
Current workplace
Christopher Fronek's current company
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8 roles · 29 years
Christopher Fronek work experience
A career timeline built from the work history available for this profile.
Manager, Document Management
Aug 2020 - Apr 2024
Sr. Specialist, Document Management
Jun 2015 - Apr 2024
Senior Document Control Specialist Ii
Alder Biopharmaceuticals
May 2010 - May 2015
Document Management Specialist
Sole administrator of company-wide controlled documentation system, including in-house departmental standard operating procedures, specifications and labels; Clinical, nonclinical and GMP protocols, amendments and reports; and third party contract manufacturing documentation, including translation management.Consistently worked to improve the Document Control and Quality systems. Past projects included:- Implementing dedicated control procedures to tighten regulatory compliance and protect original content, while still allowing easy access to documentation for employees.- Developing user-friendly form templates, implementing an Annual SOP Review program and serving as a control point for interdepartmental documentation.- Creating an on-line SOP status tracker allowing key stakeholders and reviewers to monitor progress.- Implementing a comprehensive third party documentation log to manage and track inventory (and gaps) by document type across multiple classes of documents for our primary manufacturer (in both German and English).- Administering a document translation process with an outside services vendor, including version control and cost saving document transcription when possible.
Apr 2007 - Feb 2010
Document Control Specialist Iii
Id Biomedical
Served as technical writer and editor for all on-site controlled documentation, including: Manufacturing Production Records, Raw Material and Product Release Specifications (intermediate, bulk and vialed), Certificates of Analysis, Standard Operating Procedures, Assays/Methods, Protocols and corresponding Reports (stability, development, qualification, validation).Consistently worked to improve the Document Control system. Past projects included:- Implementing a Technical Review program to ensure that documentation was reviewed and commented on by appropriate personnel.- Revising internal forms and procedures to provide a more streamlined system for external users.- Providing a system to capture supporting data and revision justifications in archived Document Change Request files.
2003 - Dec 2006
Document Control / Quality Assurance
Dendreon
Followed Good Manufacturing Practices (GMP) to implement an interdepartmental Enterprise Resource Planning (ERP) system. Developed and applied an improved template to over 200 Part Number Specifications (PNS), including labels and Source Control Documents (SCD). Drafted and released SOPs and Desk Procedures.As liaison for Quality Assurance, I worked closely with various departments including Purchasing, Manufacturing, Materials Management, Quality Control, Regulatory Affairs and Cell Processing to compile critical information and implement controlled documentation updates (Stock & Purchasing Units of Measure, MSDS information, and Shipping and Storage Conditions).
2002 - 2003
~1 yr
Writer / Researcher
Cameron Bruce Associates
Editing (Content, Developmental, Copy) & Technical Writing: 300+ page Regulatory Compliance Policy & Procedure Manuals (Safety, Emergency Preparedness, Engineering), Orientation & Training Manuals (print copy and hyperlinked), Annual & Semi-Annual Reports to the Board, Annual Program Evaluations, Management Plans.Office & Computer Management, Network Administration, Website Development & MaintenanceDeveloped Tracking Tables and compiled Performance Indicator DataPrepared Conference PresentationsPublished Articles:
1998 - 2001
~3 yrs
3 education records
Christopher Fronek education
Masters, Comparative Literature
University Of Chicago
Ba, Comparative Literature
University Of California, Davis
Ba, Psychology
University Of California, Davis
FAQ
Frequently asked questions about Christopher Fronek
Quick answers generated from the profile data available on this page.
What company does Christopher Fronek work for?
Christopher Fronek works for Omeros Corporation.
What is Christopher Fronek's role at Omeros Corporation?
Christopher Fronek is listed as Sr. Manager, Document Management at Omeros Corporation.
What is Christopher Fronek's email address?
AeroLeads has found 1 work email signal at @omeros.com for Christopher Fronek at Omeros Corporation.
Where is Christopher Fronek based?
Christopher Fronek is based in Greater Seattle Area, United States while working with Omeros Corporation.
What companies has Christopher Fronek worked for?
Christopher Fronek has worked for Omeros Corporation, Alder Biopharmaceuticals, Poniard Pharmaceuticals, Id Biomedical, and Dendreon.
How can I contact Christopher Fronek?
You can use AeroLeads to view verified contact signals for Christopher Fronek at Omeros Corporation, including work email, phone, and LinkedIn data when available.
What schools did Christopher Fronek attend?
Christopher Fronek holds Masters, Comparative Literature from University Of Chicago.
What skills is Christopher Fronek known for?
Christopher Fronek is listed with skills including Gmp, Document Management, Quality Assurance, Quality System, Sop, Validation, Gcp, and Biopharmaceuticals.
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