Employment Type : Full-Time
Job Opening for QC Analyst/Analytical Scientists in Lexington MA Cell Based - x 2 ELISA - x2 HCP- x1
We are currently working on below mentioned i., e. Job Opening for QC Analyst/Analytical Scientists in Lexington MA. Please let me know if you are interested in applying for the same.
Large Molecule QC Scientist testing, cell and gene therapy exp is desirable.
HANDS ON ASSAY Testing and Development – Cell Culture Large Molecule testing
Type of Assay and # of K's needed
• Developing techniques for the analyses of drug products and chemicals, reporting scientific results, and acting as SME for analytical techniques when needed
• Performs statistical analysis on analytical testing data of raw materials, finished products and lab batches for hypothesis testing, trend analyses, specification etc.
• Effectively uses Empower and TotalChrom to support routine analyses
• Maintains data integrity and employs good documentation practices when performing experiments
• Compares laboratory data against specifications to ensure product meet requirements
• Adheres to all internal quality standards while having the mindset of process improvement and reduction of laboratory errors
• Ensures proper usage, care, and return of calibration standards including, but not limited to, reference standards, timers, thermometers, and instrumentation
• Ensures accuracy of testing by following method/standard instructions and adhering to internal SOPs to eliminate the potential for repeat testing, deviations, and investigations
• Complete Analytical testing of the following in a cGMP environment per all global and national regulations and in a timely manner per demand: Raw Materials, Bulk Intermediate Product, Finished Product, Stability and responsible for monitoring utilities
• Complete all maintenance and calibration on assigned equipment
• Carry out assignments within the Department of Analytical Services as directed by group leader
• Perform analytical testing of Raw Materials, in-process materials, and finished products