QUALIFICATION SPECIALIST

Job Responsibilities:

Perform hardware qualification activities for ISSAQA. Manage qualification
workload to satisfy established SLAs. Provide monthly status updates to
management.Author validation deliverables documents associated with the
qualification process including summary reports and qualification reports.
Manage additional resources that may be required to successful complete
qualifications within SLA time frames. Work with Platform Engineering,
Information Security, and Validation Services management to ensure that the
qualification process is evaluated on a regular basis and that changes to the
process are implemented for ISSAQA.

Job Requirements/Education:

Candidate must have a strong infrastructure background. This includes thorough
knowledge of server operating systems including, but not limited to Microsoft
Windows 200X, Unix, Linux, and Novell. Also, working knowledge of routers is a
plus Candidate should have a FDA regulatory background, including GxPs and 21
CFR Part 11. Additional knowledge of Sarbanes Oxley Act of 2002, Prescription
Drug and Marketing Act, the Infant Formula Act is desired. Candidate should
have excellent written and verbal communication skills and should have
experienced working in a regulated environment. Candidate should have
experience authoring computer system validation documents including, but not
limited to Validation Plans, Requirement Specifications, Design Specifications,
Installation and Operational Qualification Protocols, and Summary reports.
Candidate should be able to work independently toward meeting defined SLAs.
Candidate should be familiar with Change Management processes. A working
knowledge of Remedy is a big plus.

Salary will be commensurate with experience.
Bristol-Myers Squibb is an equal opportunity employer. M/F/V/D