QC Analyst

Role Overview

The QC Analyst is an exempt level position with responsibilities for performing QC testing related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.

Major Responsibilities:

• Responsible for the completion of QC testing related to the manufacturing of autologous products for clinical trials and commercial operation in a controlled cGMP cleanroom

environment.

• Ensure testing is completed in compliance with all applicable procedures, standards and GMP regulations.

• Work with Process Development team, Quality and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products.

• Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories.

• Perform peer review/approval of laboratory data.

• Utilize electronic systems (LIMS) for execution and documentation of testing.

• Create, review and approve relevant QC documents, SOP's and WI's.

• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.

• Other duties will be assigned, as necessary

Education:

A minimum of a Bachelor's Degree in Science, Engineering or equivalent technical discipline is required or relevant years of experience within the pharmaceutical industry.

Experience:

A minimum of 1-2 years relevant work experience is required. It is preferable that the candidate have experience working in an aseptic manufacturing facility, preferably in quality assurance, manufacturing compliance, clinical quality, or cell therapy.

Capabilities, Knowledge, and skills:

• Experience in a Quality Control setting is preferred.

• Experience with aseptic processing in ISO 5 clean room and biosafety cabinets is required.

• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products is required.

• Knowledge of Good Tissue Practices is required.

• Detailed knowledge of QC test methods and related equipment is preferred

• Excellent written and oral communication skill are required

• Candidates must be able to accommodate shift schedule. Shifts include

routine weekend and evening work as required by the manufacturing

process.

• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.

• The candidate must be highly organized and capable of working in a team environment with a positive attitude under some supervision.

• Comfortable with speaking and interacting with inspectors.

• This position may require occasional travel to partner sites in NJ or PA as business demands.

• This position may require up to 10% domestic or international travel as business demands.

Language(s):

English