Validations
Provided scientific support for assay, method, equipment, or process validation for in-house testing and external studies. This included designing, executing and summarizing validation studies for microbiology assays, flow cytometry, chemistry, serology, and other analytical lab assays.

CAPA Coordination
CAPA Coordination and subject matter experts for an international Medical Device company. Assessed CAPA systems and contributed to current CAPAs. Opened new CAPAs, assessed risks (FMEA) and developed solutions. Managed project timelines for CAPA owners. Maintained regulatory compliance and cGMPs.

FDA 483 Remediation Project
Technical contributors re-validating high-volume sterile production processes for an international Medical Device company. Project oversight consulting. Addressed an FDA 483 response to maintain compliance. Document review, gap and risk analysis, re-validation (authored protocols and reports,) technical writing and compliance coaching.