This is what you will do:

The individual in this position should have a working knowledge of the cGMP QC laboratory environment and laboratory equipment associated with biopharmaceutical analysis. The QC Chemistry Senior Analyst is responsible for providing technical and laboratory support to the QC analysts and specifically working with the team to troubleshoot issues that may arise. The position requires the ability to understand and follow written SOPs, to accurately and legibly record work in real time, and pay close attention to detail.  The individual must be able to perform routine tasks with a minimum of supervision.

You will be responsible for:

·       Perform all lab functions in compliance with cGMP

·       Follow written procedures for the following tests, as trained and qualified:

·       Stability scheduling and testing.

·       Recognize and report aberrant test results and sample conditions.

·       Provide QC SME and day to day technical guidance to QC Chemistry analysts.

·       Training of new analysts in specific assays.

·       Drive continuous improvement initiatives within the QC department.

·       Lead and complete execution of investigations/CAPAs in a timely manner.

·       Provide lab support including reagent preparation, cleaning, and routine equipment maintenance.

·       Ensure training is current for all job functions performed.

·       Order, stock and receive laboratory supplies.

·       Complete all required documentation legibly and accurately.

Requirements

Qualification/Experience

• BSc in Chemistry or a biological science, with 4-7 years’ experience, or equivalent combination of education and experience
  
• HPLC (Chemistry Testing) and Review Experience
  
• A working knowledge of the cGMP QC laboratory environment, and equipment associated with testing of biopharmaceutical product.
  
• Ability to follow written procedures with close attention to detail.
  
• Ability to function with minimal supervision for routine job duties.
  

• The duties of this role are generally conducted in a lab environment.  As is typical of a lab-based role, employees must be able, with or without an accommodation to:
  
• lift/carry 15/30 pounds unassisted/assisted.
  
• work comfortably in a laboratory environment.
  
• gown/de gown PPE.
  
• Strong PC and Analytical skills
  
• Engage in communications via phone, video, and electronic messaging.
  
• Engage in problem solving and non-linear thought, analysis, and dialogue.
  
• Collaborate with others; maintain general availability during standard business hours.