QC Data Analyst
Full time
at Regeneron Pharmaceuticals, Inc
in
Ireland
Posted on April 15, 2024
Job details
Within this role you will perform a variety of activities to support release, stability, in-process and final drug product programs. As a QC Data Analyst a typical day might include, but is not limited to, the following:
- Compiling internally and externally generated data in support of compiling CofAs and SofAs
- Preparing and providing CofAs and SofAs for all lot release materials
- Working with members of manufacturing, QA, RA, and R/D to provide updates/status of CofAs, SofAs, testing issues, etc.
- Trending QC product release data to support lot release and regulatory filings
- Acting as a liaison between QC, Process Analytical Sciences, and Manufacturing group to provide trending analyses to support various activities such as manufacturing investigations, and validation studies
- Assisting in the implementation and maintenance of product release data trending program for each product candidate
- Presenting trending data at the in-depth product review
- Writing product annual release data trending reports
- Writing lot specific data trending reports for each lot to be released
- Preparing and populating matrices (databases, spreadsheets) designed to track testing and review status of release and stability samples, lot release data, etc.
- Compiling data to support QC department metrics and performance tracking
- Assisting with the improvement effort of streamlining the review and release process
- Attending meetings as required on behalf of Quality Control to update partners (Drug Supply, External Manufacturing, QA) as to status issues pertaining to release data
- Attending meetings to keep informed of development and manufacturing priorities and activities
- Ensuring compliance with applicable cGMP regulations and SOPs
- Maintaining and updating relevant SOPs for data review and reporting as needed
- Meeting specified timelines to support release and regulatory filings
- Compiling with all pertinent regulatory agency requirements
- Participating in required training activities
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