Description :
Will serve as Quality Assurance oversight for Quality Control (QC) data, documentation, and projects as well as Validation documentation and projects.
The position will also assist with these activities for third party manufacturers. This position works directly with QC, Validation, and Project management to integrate Quality into industrial operations.
Serve as QA reviewer and approver of QC release, stability and raw material data
Serve as QA reviewer and approver of site validation protocols including production equipment, computer systems, laboratory equipment and methods
Review SOPs for accuracy and compliance; draft revisions for updates as necessary.
Review and approve OOS / OOT investigations for raw materials, intermediates and finished product testing.
Review and approve investigations as it related to the execution of the project or validation.
Provide QA reviews and approvals of QC and / or Validation procedures, methods, change controls, CAPAs, deviations, and other documents, as necessary.
Additional Skills & Qualifications :
BS Degree strongly preferred but can consider AS Degree with desired work experience.
7 Years of Pharma Industry experience including time in an analytical laboratory as well as validation procedures, tech transfer, process development, etc. 7 years + preferred
Ideal experience with reviewing validation protocols within production / manufacturing processes. Must have either high level QC Data Review / Investigation experience or actual QA Auditing experience from a pharma company.
Experience Level : Expert Level
Expert Level
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