Quality Control Data Analyst

We are looking to hire a Quality Control (QC) Data Analyst for a Monday-Friday, 8am-4:30pm schedule. Regeneron successfully manufactures a range of biopharmaceuticals for patients worldwide, including our approved therapeutic proteins and those involved in clinical studies. Our QC Analysts are on the front line, performing a variety of activities to support release and stability programs of these life changing products to ensure that they are safe for our patients.

As a Quality Control Analyst, a typical day might include the following:

• 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

• Act 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.
• Assist in the implementation and maintenance of product release and stability 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 (Drug Supply, External Manufacturing, QA) as to status issues pertaining to release data
• Attend meetings to keep informed of development and manufacturing priorities and activities
• Ensures compliance with applicable cGMP regulations and SOPs
• 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.
• Participates in required training activities.

This role might be for you if:

• Enjoy working in a fast-paced environment and you have the innate ability to balance multiple tasks, prioritize them and execute them independently, while excelling at keeping all impacted parties well advised
• Have a basic understanding of Microsoft Suite (Word, Excel, Powerpoint)
• Can follow a set of instructions with exceptional attention to detail
• Ability to work in a team environment and communicate effectively to accomplish shared goals
• Develop and drive scientific and/or business-related improvement ideas

To be considered for the Quality Control Analyst you must be willing and able to work 1st shift, Monday-Friday, 8am-4:30pm schedule. You must have a BS/BA in Chemistry, Biochemistry or related field and some relevant work experience. Experience working in a cGMP pharmaceutical Quality Control Laboratory is preferred but not required.