Director Quality Assurance Regulatory Affairs @ IlluminOss Medical Inc (September 2018 - January 2021)
Software Quality Assurance Eng III @ Eliassen Group (Currently contracting with Philips Healthcare (April 2017 - June 2018)
Sr Specialist QA (Risk Management) @ (September 2014 - April 2017)
Sr Specialist QA (Validation) @ (March 2013 - February 2017)
Sr Specialist, QA (CAPA) @ (December 2004 - March 2013)
Director, QA @ (November 1997 - November 2004)
Mark Bliss Education
University of Maine at Orono
Bachelor of Science (BS) (Zoology/Animal Biology)
1977-1981
Nathaniel Hawthorne College 1975-1976
Mark Bliss Skills
Batch Release
Product Release
Root Cause Analysis
Risk Analysis
Process Improvement
Validation
21 CFR Part 11
Change Control
GMP
CAPA
Sop
FDA
GxP
Cleaning Validation
Iso 9000
ISO 13485
Medical Devices
Biotechnology
Quality System
Quality Assurance
Corrective and Preventive Action (CAPA)
U.S. Food and Drug Administration (FDA)
Pharmaceutical Industry
Standard Operating Procedure (SOP)
Biopharmaceuticals
Verification and Validation (V&V)
U.S. Title 21 CFR Part 11 Regulation
Cross-functional Team Leadership
Management
Risk Management
Complaint Investigations
Nonformance Investigations
Internal GMP Auditing
TrackWise
Supplier Auditing
Quality Systems Design
Verification and Validation V&V
Corrective and Preventive Action Capa
Cross Functional Team Leadership
u.s. Food and Drug Administration Fda
Standard Operating Procedure Sop
Corrective and Preventive Action
u.s. Food and Drug Administration
Standard Operating Procedure
Verification and Validation
Mark Bliss Summary
Mark Bliss, based in Upton, MA, US, is currently a Senior QA Manager at Ocular Therapeutix, Inc.. Mark Bliss brings experience from previous roles at Ocular Therapeutix, Inc., IlluminOss Medical Inc, Eliassen Group (Currently contracting with Philips Healthcare and Amgen. Mark Bliss holds a 1977 - 1981 Bachelor of Science (BS) in Zoology/Animal Biology @ University of Maine at Orono. With a robust skill set that includes Batch Release, Product Release, Root Cause Analysis, Risk Analysis, Process Improvement and more. Mark Bliss has 2 emails and 1 mobile phone numbers on RocketReach.
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