Job Description

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.

Essential Functions

• Review of Stability reports, data evaluation, and record management
• Review and approval of CMO documentation for batch production
• Review batch records, address discrepancies, and escalate where required to management
• Review, input, and routing of quality agreements
• Quality record management; deviations, change controls, CAPAs
• Monitoring cold-chain transportation, for both qualification and routine
• Annual Product Quality Review assessment and authoring (certain sections)
• Writing quality systems documents
• Working within master Control for authoring, reviewing, routing, and approving
• Regular telephone and email communication with internal partners to ensure timely manufacture and resolution of quality issues for products.
• Support continuous improvement projects

Education / Experience / Skills:

• Bachelor’s Degree in a scientific discipline, preferred experience working within - - Quality roles with increasing responsibility.
• Direct experience working with Quality Systems (deviations, change controls, training, supplier qualification, and document management systems)
• Knowledge of cGMP requirements for pharmaceutical manufacturing, specifically CFR 210/211
• Sterile injectable pharmaceutical experience preferred
• Knowledge of Microsoft Office Suite
• MasterControl experience a plus

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