Summary:
The position is responsible for assisting in the review and writing of quality systems documentation and working with internal and external counterparts at the CMO and cross-functional team members. The position is responsible for appropriate escalation to Manager/Director level management and above.
Must have:
Review of quality documentation from contract manufacturers and labs. This may include stability reports, C of A’s, batch records , etc. Technical review and writing of annual p roduct quality reviews. Writing, reviewing and routing of Quality Agreements . Working with contract manufacturers to resolve comments on quality documentation.
Documentation
Data reviews
Required 3 years Pharmaceutical experience or medical device
Bachelor Degree required
Master control or related systems experience
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