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Job: QC Analyst, Bioassay, Cellectis, Raleigh, NC
QC Analyst, Bioassay
Raleigh, NC 27616 United States
The Quality Control Bioassay Analyst completes daily QC Bioassay activities and documentation including but not limited to flow cytometry, cell counting, ELISA and Polymerase Chain Reaction (PCR) testing. The QC Bioassay Analyst executes method validation protocols, analyzes raw data, and troubleshoots unexpected events that occur during performance of the bioassay methods, method transfer, and method validation. The analyst may participate in selecting and qualifying analytical instruments, writing Analytical Test Methods and operational SOPs.
Responsibilities include but are not limited to the following:
Performs routine QC tests for product release, stability, and in-process monitoring.
Performs second analyst verification of assay results and raw data.
Complies with applicable US and European CGMP regulations, corporate policies and company Standard Operating Procedures.
Provides input based on knowledge and experience on QC Bioassay, procedures and CGMP issues including but not limited to flow cytometry, cell counting, ELISA, and PCR testing.
Participates in Bioassay analytical method transfer and validation.
Provides Bioassay related support to all GMP departments
Ensures timely issuance, review and approval of Bioassay testing results
Participates in laboratory deviation investigations and corrective and preventive actions as required.
Interfaces with colleagues to ensure effective corrective and preventive actions are implemented for any recurring product/process discrepancies
Other duties as assigned by the Bioassay Laboratory Supervisor or Director of QC as needed.
Education & Experience
BS degree in a Life Science, with 2-3 years of relevant Bioassay experience in a biopharmaceutical or pharmaceutical company.
Experience writing Standard Operating Procedures and Work Instructions
Experience executing test methods for the Bioassay Laboratory. Experience performing FACS analysis is required.
Technical Skills Requirements/Core Competencies
Able to carry out routine work by following established procedures and requires detailed instructions on new projects or assignments
Able to work on problems of limited scope and complexity where analysis of a situation/data requires review of a variety of factors
Follows standard practices and procedures in analyzing situations or data from which answers can be readily obtained.
Analytical and problem-solving skills
Detail-oriented with strong organizational skills
Strong written and oral communication skills
Ability to prioritize and multi-task is essential
Must be able to work independently and effectively within a team-oriented environment
Physical Position Requirements
Requires the ability to sit or stand at a computer for long stretches of time and type. Frequently operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer. The person in this position needs to occasionally move about inside the office to access file cabinets and office equipment. Frequently walks around the laboratory, manufacturing, warehouse, and office areas to perform their job functions. Safely works with hazardous and biohazardous materials using appropriate personal protective equipment (PPE). Requires the ability to follow proper gowning procedures and work in cleanrooms for uninterrupted periods of time of at least 4 hours. May lift objects up to thirty pounds.
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North Carolina Biotechnology Center