Jon A. Berdahl
948 Deer Trail Rd., Boulder, Colorado 80302
Home: 720-287-3607 | Cell: 612-867-4714 | [email protected]
Summary
 Experience: more than 25 years in Quality leadership and analytical chemistry positions in cGMP, QSR
(ISO 13485), GLP environments, and other regulated environments
 Leadership: strong management and mentoring skills; building high performing teams with a strong
sense of mission; implementing quality transformation projects; successful management of large quality
remediation projects; and effective OOS, OOT, CAPA investigations
 Analytical: developing and validating HPLC, LC/MS, GC, GC/MS, NMR, FTIR, ICP, IC, UV/VIS and other
analytical methods
 Technical Writing: test methods, protocols, reports, investigations, regulatory submissions, SOPs, and
Quality Plans
 Regulatory: Regulatory Affairs Certification (RAPS US RAC – current certification pending renewal), CMC,
CBE, and PAS submissions
Professional Experience
Principal, Owner
Arete Quality Consulting, Boulder, Colorado
2014 – Present
 Principal Consultant serving the pharmaceutical, medical device, and combination product industries
 Specializing in GMP, GLP, QSR consulting in the following areas:
o
Quality Assurance / Quality Control
o
Audit / Review and Remediation
o
Analytical Method Validation / Transfer / Verification
o
Technical Writing
o
Laboratory Optimization
o
Training
Manager, Quality Control Technical Services
Hospira Inc., Boulder, Colorado
2012 – 2014
 Managed a team which partnered with Analytical Development in the development of analytical
methods for new commercial APIs and led the validation, transfer, verification, and training of these
methods in the QC laboratory
 Provided expert support for quality systems, method development / validation, specification
development, stability trending, technology transfer, and investigations
 Successfully managed retrospective review of 208 OOS investigations and 584 data invalidations by
former FDA Investigators. Successfully defended all potential on-market product impacts through
supplemental investigation, statistical analysis and technical risk assessment reports
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Manager, Quality Control Laboratory
Hospira Inc., Boulder, Colorado
2011 – 2012
 Managed all QC laboratory testing in support of API development, manufacturing and stability
 Represented QC in FDA inspections and regulatory audits
 Successfully managed the QC method validation, verification and transfer activities for three new APIs
 Developed stability tracking datasheets with graphical trending
 Led laboratory OOS and deviation investigations
 Designed and oversaw construction of new state-of-the-art pharmaceutical QC laboratory
Principal Engineer, Pharmaceutical Quality / Design Assurance
Boston Scientific, Maple Grove, MN
2004 – 2011
 Quality team member on new product development teams for quality and compliance related
deliverables for pharmaceuticals, combination products and medical devices
 Managed the qualification of new bio-absorbable polymers and other materials from GMP and non-
GMP suppliers through strategic testing, audit, and risk management
 Quality review of manufacturing batch records, generation of CoA’s and review of laboratory test data
 Managed the validation and transfer of analytical chemistry methods supporting development, raw
material acceptance, manufacturing, stability, and release of new drug products at US and European
sites
 Developed and validated drug assay, impurities, dissolution, residual solvents, IVIVC, and identification
methods
 Led team which completely rewrote the Global Analytical Chemistry Validation SOP and introduced
scaled validation levels to meet regulatory requirements (GLP/IDE/PMA) and analytical lifecycle
Director, Corporate Quality Control
Bay West, St. Paul, MN
2003 - 2004
 Oversaw all Quality Systems and audit operations
 Developed project quality plans, quality systems and procedures
 Audited analytical laboratories and wrote project analytical final reports.
Director, Information Technology / Project Analytical Chemist
Service Engineering Group, St. Paul, MN
 Database Administrator (MS SQL Server) and MS Exchange Email Server Administrator
 Managed all quality systems for large multi-million dollar projects
 Quality review of analytical data and audit of analytical laboratories
 Project management of analytical testing and submissions to regulatory agencies
 Technical writing of project analytical reports
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2001 – 2003
Laboratory Manager / Study Director, Preclinical GLP
Pace Analytical Services Inc., Minneapolis, MN
1997 – 2001
 Established cGMP and GLP quality systems
 Managed analytical laboratory involved in GLP and cGMP testing (GC, GC/MS, LC/MS, and LC/MS/MS)
 Study Director on several preclinical GLP animal toxicology studies and pulmonary biopolymer stability
studies
 Validated GLP bioanalytical methods (LC/MS/MS)
Additional Laboratory Management Experience
Managed Cargill Corporate Analytical Services Laboratory (Minnetonka, MN)
Managed Huntingdon Engineering Analytical Chemistry Laboratory (St. Paul, MN)
Managed Twin Cities Testing Analytical Chemistry Laboratory (St. Paul, MN)
Education and Professional Training
Bachelor Degree, Chemistry, St. Olaf College, Northfield, MN
RABQSA Certified Quality Management System (QMS) ISO/IEC 17025 Lead Auditor Training
Developing Specifications for Drug Substances and Drug Products (CfPA)
Managing OOS and CAPA Investigations
Software Experience
Trackwise Compliance Management System
Minitab Statistical Software
Stat-Ease Design Expert Experiment Design Software
Waters Empower 3 Chromatography Data System (Systems Administrator)
Multiple Laboratory Information Management Systems (LIMS)
Oracle and MS SQL Server (DBA); all MS Office Applications
Professional Affiliations
Rocky Mountain Regulatory Affairs Society (RMRAS)
Regulatory Affairs Professionals Society (RAPS)
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Albert B. Kao - Princeton University