Pharmaceutical QC Data Reporting Analyst

about 1 month ago
Full time role
In-person · Rensselaer, NY, US... more
  • Ability to work independently and as part of a team in a fast-paced, client facing environment.
  • Self-motivated, adaptable, and a positive attitude
  • Excellent communication (oral and written) and attention to detail

  • Compile internally and externally generated data in support of compiling CofAs and SofAs.

  • Prepare and provide CofAs and SofAs for all lot release materials

  • Work with members of manufacturing, QA, RA, and R/D to provide updates/status of CofAs, SofAs, testing issues, etc.

  • Trend QC product release data to support lot release and regulatory filings
  • Provide trending analyses to support various activities such as manufacturing investigations, and validation studies.
  • Assist in the implementation and maintenance of product release and stability data trending program for each product candidate
  • Prepare product annual release and stability data trending reports
  • Prepare monthly release data trending reports or as required  
  • Perform reference standard trending
  • Perform trending of relevant systems suitability parameters
  • Prepare stability trend reports
  • Prepare and populate matrices (databases, spreadsheets) designed to track testing and review status of release and stability samples, lot release data, etc.
  • Compile data to support QC department metrics and performance tracking
  • Assist with the improvement effort of streamlining the review and release process
  • Ensures compliance with applicable cGMP regulations and SOPs
  • Meet specified timelines to support release and regulatory filings
  • Complies with all pertinent regulatory agency requirements.
  • Participates in required training activities.