Computer System Quality Assurance, Compliance, Validation

Jeff Berman

215-***-****

*************@*****.***

*** ********** ***** *****, *********, PA 19053

Professional Summary

Reliable and experienced professional with a strong background in quality management, compliance and project management. Recently retired but now seeking part-time opportunities to stay active, contribute meaningfully and bring value through proven skills on project management and operations. I am known for dependability, work ethic, and cheerful disposition.

Key Skills

-Leadership

-Team Player

-Organization and Planning

-Problem Solving

-Cross Functional Collaboration

-Verbal and Written Communications

-MS Office Products

-Understanding of technology

Experience

Computer System Validation, Mallinckrodt Pharmaceuticals, Contractor

Remote, 11/2023- 05/2024

-Hired to help eliminate the backlog of periodic reviews and aid in the review process of executed test scripts.

-Assessed elements of validations packages to confirm that the computer system was maintained in a validated state for the period examined.

-Identified risks and compliance gaps to federal regulations and company procedures.

Quality Reviewer, Novavax Pharmaceuticals, Contractor

Remote, 04/2022-06/2023

- Coordinated multiple quality assurance initiatives to improve team performance and support continuous improvement.

- Evaluated validation documentation to ensure they meet company procedures and regulatory requirements.

Senior Specialist IT Quality Assurance, Organon Pharmaceuticals

Remote, 04/2021-04/2022

-Managed oversight of GxP computerized solutions to ensure compliance with company policies and procedures as well as federal and international regulations.

-Supported the preparation, review and approval of validation documentation and quality operations including core requirements, SOP’s and best practices.

-Worked closely with internal teams to complete projects and meet deadlines.

Previous Employment

Quality Auditor II, Bioclinica, Remote, 11/2020-04/2021

Senior Quality Specialist, Bristol Myers Squibb, Princeton, NJ, 04/2019-07/2020

Corporate Computer System Validation Lead, Lannett Pharmaceuticals, Philadelphia, PA 12/2016-10/2018

Validation SME/CSV SME/ Quality Analyst, Various Pharmaceutical Companies and Various Locations, Contractor, 07/2013-11/2016

Quality Manager, Business & Decision, Wayne, PA., 1/2011-07/2013

Clinical Quality Manager, Numoda Corporation, Philadelphia, PA 06/2009-12/2010

Quality Assurance Specialist, Wyeth Pharmaceuticals, Frazer, PA, 01/2002-05/2009

Project Manager, Wyeth Pharmaceuticals, Frazer, PA, Radnor, PA 01/1996-01/2002 .

Education

Penn State University, Abington, PA, Project Management Certificate, 1999

Bachelor of Business Administration, Accounting, 1973

Temple University, Philadelphia, PA,

Some Validation Projects Worked On

SAP

SAP Merge

SAP Sweden

SAP Warehouse

Orbit

docuBridge

Optel Serialization

Learning Management System

Box

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