Quality Investigator

The Scientist/Engineer is responsible for leading manufacturing and QC investigation reports in support of operations. This includes execution of thorough root cause investigations, interviewing personnel, hypothesis testing and interpretation of results, authoring investigation reports, identifying corrective and preventive actions (CAPA), and troubleshooting complex problems. The successful incumbent must interface closely with different functional organizations, including Quality Assurance teams.

Required Competencies: Knowledge, Skills, and Abilities:

• Working experience of deviation investigations utilizing root cause analysis tools.

• Working experience in the CAPA process and ability to identify and verify effectiveness.

• Technical writing skills and ability to collaborate effectively in cross functional teams.

• Proven ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP requirements.

• Ability to support health authority inspections.

• Knowledge of data trending and tracking, including use of statistical analysis software a plus.

• Demonstrate advanced problem-solving ability / mentality, technical adeptness and logical thinking.

• Ability to set priorities, manage timelines and effectively react/manage changing priorities.

• Ability to work with management (global and site) and support corporate and departmental goals.

• Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers.

• Ability to utilize electronic Quality systems such as eQRMs (Enterprise Quality and Regulatory Management system).

• Hands on experience preferred with CAR-T or biopharmaceutical manufacturing and Quality Control.

• Ability to train new team members on the investigation process

Education and Experience:

• Requires a bachelor’s degree in science or engineering, preferably in Biochemistry, life sciences or related engineering discipline (advanced degree preferred).

• Minimum 3 years of relevant work experience, preferably in a health authority regulated environment.

• Previous experience working in a biopharmaceutical manufacturing facility is preferred (CAR T a plus).

• An equivalent combination of education and experience may substitute.