Validation and Quality Assurance Specialist - Pharma

We have an immediate opening for a Validation/QA Specialist to join our team in our Princeton, NJ, office to support software implementation projects. The individual will be responsible for validation planning and execution management, including development of validation plans and IQ/OQ/PQ protocols; development of test plans, test scripts, and test execution; requirements gathering and analysis documentation; development of user requirements and functional requirement specifications; development and coordination of tracability matrices; and management of defect and issue tracking.
REQUIREMENTS


• 8-10 years of experience in the pharma/IT industry

• 3-5 years experience as QA and/or Validation specialist or lead with COTS and home-grown systems

• Experience with SDLC and where and how validation activities fit

• Strong business analyst and communication skills

• Strong collaboration skills with clients and technical teams

• Experience in authoring and reviewing validation and system/business requirements documentation

• Experience with 21CFR Part 11 and systems validation and audits

• Experience in authoring and reviewing validation plans

• Experience in authoring and reviewing IQ/OQ/PQ protocols and scripts

• Experience in analyzing and collating validation results and authoring validation reports

• Documentum or other document management systems experience a plus

• Siebel or other CRM systems experience a plus

• Some travel may be required



People are our most vital resource. We value skill, knowledge, imagination, enthusiasm, integrity, and commitment. Our company provides an environment that attracts highly qualified personnel and offers the satisfaction of working in a challenging and successful setting. Here you will have the opportunity to work with a team of talented professionals doing world-class work.

EOE