QC IT Validation SpecialistApply Now
Location: Framingham, Massachusetts 01702
Employment Type: Contract
Contract Length: Temp to Perm
Job Summary: The laboratory IT validation specialist function will write user requirements, test protocols, and IT system qualification reports for GMP computerized laboratory systems. The person in this role will write test scripts to evaluate 21 CRF Part 11 compliance as well as to be knowledgeable in GMP compliance.
- Write user requirement specification documents according to LFB policies and procedures.
- Write and execute tests scripts for validation of laboratory systems.
- Follow applicable SOPs and policies for validation
- Author validation protocols and reports
- AS / BS degree in Information Science or Biological / Chemical Science.
- Experience Validating complex computerized Laboratory systems such as Chromatography systems, Gel scanners and Microplate readers (e.g. OpenLab, Chemstation, Softmax, Image Lab, etc.)
- Understand GMP and 21CFR Part 11 compliance and validation.
- 5+ years in GMP QC/IT environment is required.
- Experience in authoring, SOPs protocols and technical reports.
- Ability to work independently and have good judgment and organizational skills.
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