Validation Associate/Specialist (Updated 5/9/08)

Essential Duties and Responsibilities

Performs a wide variety of activities to ensure compliance with applicable regulatory requirements. Specific responsibilities will include:

 

Write and execute or oversee execution of equipment and computer IQ/OQ/PQ protocols and reports.

 

Assist in validation initiatives including execution of protocols, compiling and reviewing data, writing summary reports and other required activities.

 

Assist in other QA Activities, as required.

 

Qualifications

Requires ability to plan, prioritize and organize diversified workload.  Must have excellent technical writing, verbal communication skills, attention to detail and the ability to work on multi-departmental initiatives. 

 

Education and/or Experience

BS experience in a scientific discipline and a minimum of 1-2 years related experience in the biotechnology industry, with working knowledge of cGMP.

 

 

*Candidates with additional experience may be considered for a Validation Specialist opportunity.

*No relocation offered.

 

For consideration please send resume and cover letter to careers@insmed.com