Senior Validation Associate

Senior Validation Associate

 

Octagon Research Solutions, Inc., is a fast growing Development Partnering Organization (DPO), which acts as a virtual partner in supporting its Biopharmaceutical & Pharmaceutical clients throughout the entire clinical research, development and submissions process.  Based in Wayne, PA, Octagon successfully meets their client's unmet needs by integrating information technology and multidisciplinary services to create a complete solution.  We offer unparalleled practical knowledge and industry expertise that spans the clinical research and development lifecycle. 

 

Currently, we are experiencing significant growth and are conducting a nationwide search in efforts to expand our Validation Team.  Reporting directly to the Validation Manager, the Validation Associate will be responsible for the following: 

 Responsible for supporting and / or conducting validation efforts for internal projects. Projects will include both commercial off-the-shelf as well as in-house developed systems.Authoring, maintaining and executing software validation documentation (test protocols and scripts).Conduct quality reviews of validation materialsParticipate in validation activities at client sites as required.Perform ad hoc project work as assigned.

 

The successful candidate will have any combination of the following skills/experience: (not all are necessary, but strength in many would be ideal):

 Four-year degree Minimum of 3 to 4 years professional experience in pharmaceutical computer systems validation Strong attention to detailsAbility to communicate effectivelyProficiency with the Microsoft Office suite of tools required, especially Microsoft Word and Excel.Strong writing, oral & presentation skillsAbility to identify and escalate issues, and to suggest possible resolutionsUnderstanding of IT related terminology, operating systems, applications and environments.Detailed knowledge of SDLC methodologiesKnowledge of 21 CRF Part 11 guidance and requirements.

 

Octagon is an Equal Opportunity Employer with an outstanding corporate culture.  We are an emerging growth company providing a business casual environment, strong benefits, competitive compensation and outstanding career advancement opportunities.  The entrepreneurial setting, coupled with our financial stability, has made us an employer of choice, and one of the most sought after Life Sciences employers in the area.  Please visit us at www.octagonresearch.com to learn more about how we are revolutionizing the drug development lifecycle.

 

To apply, please forward your resume to Laurie Koch, Recruiting Specialist at lkoch@octagonresearch.com .

 

 

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