We found the following information about Marc Albert Monette at Nsf International, where this person has worked as a Principal Consultant, Nsf Pharma Biotech since 2013. Marc's total work experience is over 37 years, during which time Marc Albert Monette had at least 14 jobs at different places to develop professional skills. Marc studied at the University of Toronto - Rotman School of Management from 1990 to 1992. This expert received the following certifications: Certified Software Quality Engineer, Crisc-Certified-In-Risk-And-Information-Systems-Control, and Certified Manager of Quality/Organizational Excellence (Cmq/Oe). Marc Albert Monette is experienced in English. Marc Albert Monette currently lives in Irvine, California. You can contact with Marc by searching for phone number or email address or find full info by requesting access to this professional's additional details.
Name variants:
Mark Monette
Last updated Jun 05, 2024
Contact Information
Last Update
Jul 14, 2022
Email
mm**@cox.net, mm**@nsf.org
Location
Irvine, CA
Company
Workplace
Principal Consultant, Nsf Pharma Biotech
Ann Arbor, MI
Industry
Public Safety, Commercial Physical Research Testing Laboratory, Commercial Physical Research, Nsk
Colleagues
Work History
Principal Consultant, Nsf Pharma Biotech
789 north Dixboro Rd, Ann Arbor, MI 48105
Jun 2013 — Sep 2019
Director, Qa - Csv and Gxp Data Integrity
6154 Nancy Ridge Dr, San Diego, CA 92121
from Sep 2019
Senior Consultant and Principal
1300 south Bristol St, Santa Ana, CA 92704
Developed and implemented Quality Management Systems for life science clients.
Authored IOQ templates for group of 13 consultants to increase productivity.
Salesforce.com GxP Validation S...
2007 — Sep 2019
Consultant à   Validation
64550 Research Rd, Bend, OR 97701
Audit and assessment of MasterControl document management supplier.
Integration of vendor test evidence to facilitate right sizing validation effort.
2010 — 2010
Senior Manager à   Regulatory Affairs and Compliance
2000 Galloping Hill Rd, Kenilworth, NJ 07033
2008 — 2009
Consultant à   Validation
1700 Saturn Way, Seal Beach, CA
Performed GMP/Part 11 analysis and assessment for lab systems
Authored and executed IOQs and authored validation deviation reports and validation summary reports for the lab systems.
Auth...
2009 — 2009
Consultant à   Validation
Authored and delivered system life cycle documentation for Monitoring System and Data Archival and Retrieval System to prepare Biotech production facility for market supply FDA approval. Col...
2007 — 2008
Consultant and Trainer
10815 Rancho Bernardo Rd SUITE 120, San Diego, CA 92127
International Pharmaceutical Academy, Toronto Successfully delivered a workshop/seminar providing Canadian and US pharmaceutical industry participants with best practice training on System L...
2007 — 2007
Associate Director, Systems Compliance
225 Binney St, Cambridge, MA 02142
Associate Director, Systems Compliance
Planned, coordinated and directed efforts to design, validate and implement new systems with lifecycle document deliverables including quality plans,...
2001 — 2004
Consultant and Senior Validation Engineer
10815 Rancho Bernardo Rd SUITE 120, San Diego, CA 92127
Senior Validation Engineer
Developed core quality assurance processes including corrective action, complaint management, document and records control, contract administration, internal aud...
2000 — Dec 2001
Chief Executive Officer and Quality Manager
Trained and implemented programs for: good documentation practices and associated software tools; basic and advanced policy and writing; instrumentation and test equipment calibration and m...
1997 — 2000
Service and Sales Manager
Managed life science instrument service and sales operations for ISO 9002 registered calibration and repair services, along with distribution sales of over 200 instrument and equipment produ...
1995 — 1997
Education
Occupations
Executive
Director
Senior Advisor
Operations Manager
Advisor
Skills
Validation
Fda
21 Cfr Part 11
Change Control
Gmp
Quality Assurance
Pharmaceutical Industry
Quality System
Computer System Validation
Sop
Gxp
Medical Devices
Quality Auditing
Regulatory Affairs
Biotechnology
Glp
Capa
Biopharmaceuticals
Gamp
Software Documentation
V&V
Gcp
Iso 13485
Iso 14971
Life Sciences
Quality Management
Design Control
Quality Control
Salesforce.com Development
Salesforce.com Gxp Validation
Sharepoint
Data Integrity
Cloud Applications
Cloud Computing
Cloud Security
Regulatory Requirements
Data Governance
Iso 9001