José Rivera, MS, ASQ CSQE

Past

• Manager, CARES Administration at Bristol-Myers Squibb
• Sr. QA Computer Validation Engineer III at ImClone Systems
• Validation Engineer II at Schering Plough Inc

• Technical Assistant at Schering-Plough

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1 more...

Education

• Nova Southeastern University
• Kean University
• Universidad de Puerto Rico

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Connections

74 connections

Industry

Pharmaceuticals

Websites

• My Website

José Rivera, MS, ASQ CSQE’s Summary

Over fourteen (14) years in the bio-pharmaceutical industry, with strong emphasis in the implementation, validation and compliance of Information Systems in an FDA regulated environment. Experienced as a Quality Assurance (QA) professional in the development, review and approval of computer system validation (CSV) documentation. Skilled Information Systems auditor with experience in compliance with 21 CFR Part 11, GAMP guidelines, computer validation and Information Technology infrastructure. Experienced with the implementation and validation of information systems including but not limited to Trackwise, ARISg, Pilgrim, Documentum, SkillPad, Empower Chromatography Systems, Programmable Logic Controllers (PLC’s) and Building Management Systems (BMS). Certified Software Quality Engineer (CSQE)-Certification # 3737. Bilingual (English/Spanish). Recipient of 2005 Extraordinary Effort Award.

José Rivera, MS, ASQ CSQE’s Specialties:

Information Systems Validation, compliance, Project Management,

José Rivera, MS, ASQ CSQE’s Experience

• Manager, CARES Administration

  Bristol-Myers Squibb

  (Public Company; 10,001 or more employees; BMY; Pharmaceuticals industry)

  November 2007 — October 2008 (1 year)

• Sr. QA Computer Validation Engineer III

  ImClone Systems

  (Public Company; 1001-5000 employees; IMCL; Biotechnology industry)

  October 2000 — October 2007 (7 years 1 month)

• Validation Engineer II

  Schering Plough Inc

  (Privately Held; 10,001 or more employees; SGP; Museums and Institutions industry)

  June 1997 — September 2000 (3 years 4 months)

• Technical Assistant

  Schering-Plough

  (Public Company; 10,001 or more employees; SGP; Pharmaceuticals industry)

  February 1994 — June 1997 (3 years 5 months)

José Rivera, MS, ASQ CSQE’s Education

• Nova Southeastern University

  Ph.D., Information Systems, 2005 — 2010 (expected)

• Kean University

  M.S., Management Information Systems, 1999 — 2002

• Universidad de Puerto Rico

  B.S., Chemical Engineering, 1988 — 1993

Additional Information

José Rivera, MS, ASQ CSQE’s Websites:

• My Website

José Rivera, MS, ASQ CSQE’s Groups:

•    American Society for Quality
•    Computerized Systems Validation
•    Kean University Alumni of New Jersey
•    21 CFR part 11
•    Universidad de Puerto Rico - Recinto Universitario de Mayaguez
•    Nova Southeastern University Graduate School of Computer and Information Sciences
•    ASQ Software Division

José Rivera, MS, ASQ CSQE’s Contact Settings

Interested In:

• career opportunities
• consulting offers
• new ventures
• job inquiries
• expertise requests
• business deals
• reference requests
• getting back in touch