James Estrella Email & Phone Number

Cambridge, Massachusetts

Allston, MA

• Quality Compliance
• Ensure all gaps are closed and the site is inspection ready.
• Chair site Quality Council meeting; publish agenda and minutes.
• Assist in hosting internal and external audits by various health agencies (e.g. FDA, EMA, etc.)

Allston, MA

• 2013 – Present Following a reorg, job function changed from project based to role based, to support Consent Decree Work Plan third party verification activities by Quantic.
• Received request, collected and presented evidence to third party verifiers (for CDWP Numbered Steps).2012 – 2013
• Supported CD remediation teams which revolved around document creation/revision and DCR processing.

Allston, MA

• Wrote and reviewed SOPs and OJTs for the Quality Assurance Fill Finish/Labeling and Packaging group.
• Performed lot disposition for labeled and packaged drug product for US and foreign markets.
• Closed deviations and CAPAs; performed root cause analysis and wrote investigations.
• Wrote Change Controls associated with Fill Finish/Labeling and Packaging.

Cambridge, MA

• Developed CMC sections for US, Canadian, and European regulatory filings.
• Reviewed data incorporated into CMC regulatory filings.
• Reviewed and revised technical SOPs.
• Authored Quality Manual for the Quality Control Laboratory, which outlined policies and procedures.