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QC Data Analyst
Ref No.: 18-42377
Location: Rensselaer, New York
Position Type:Contract
Pay Rate : $ 18.00 - 20.00 /Hour
Skill Type
Skill Type:Information Technology
QC Data Analyst will performs a variety of activities to support release and stability programs on a contract basis expected to last 12 months.
Responsibilities include:
• Trend QC product release data to support lot release and regulatory filings
• Act as a liaison between QC, Process/Analytical Sciences, and Manufacturing groups to provide trending analyses to support various activities such as manufacturing investigations, and validation studies
• Assist in the implementation and maintenance of product release data trending program for each product candidate
• Presents trending data at the in-depth product review
• Write product annual release data trending reports
• Write lot specific data trending reports for each lot to be released
• 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
• Attend meetings as required on behalf of Quality Control to update partners as to status issues pertaining to release data.
• Maintain and update relevant SOPs for data review and reporting as needed
• Meet specified timelines to support release and regulatory filings
• Complies with all pertinent regulatory agency requirements
• Compile internally and externally generated data in support of compiling CofAs and SofAs
• Prepare and provide CofAs and SofAs for all lot release materials
Education and Experience:
  • Requires Bachelors degree in Chemistry, Biology or possibly a math degree could work as well.
  • Relevant hand on work experience will be necessary as well
  • Experience working in a cGMP pharmaceutical Quality Control Laboratory is preferred but not required.