Cell Therapy QC Microbiology Analyst

Overview/Role Purpose:

The QC Analyst will act as a team member of the Quality Control department to support production cell therapy drug lots for customers. Also participate in quality testing for ongoing customer stability studies. Provide on-time, high quality results to meet Manufacturing demands.

A QC Analyst: Applies job skills and company's policies and procedures to complete a variety of tasks. Works on assignments that are semi-routine in nature where ability to recognize deviation from accepted practice is required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. 

Key Accountabilities and Duties:

Running test samples for In-Process, Lot Release and Stability studies including bioburden, endotoxin, TOC, sterility, aseptic process simulations

Reviewing assays

Training others

Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods

Perform other duties as assigned. 

Minimum Required Qualifications/Skills:

Bachelor or Associates Degree. Preferred area of study in Microbiology, Biochemistry or Related Science field

2+ years industry experience, preferably in a cGMP environment

Use of Microsoft Suites (Word, Excel, Powerpoint)

Use of Laboratory computer systems

Potential previous use of GMP Quality Systems such as: TrackWise, LIMS

Solid ability to speak publicly.

Solid ability to interpret data.

Perform assigned, complex and/or varied tasks with guidance from Supervisor.

Prioritization and problem solving.

Comprehend and follow instructions.

Direct, control and plan tasks/projects.

Brainstorming

Solid ability to communicate in both written and verbal format.

Exercises judgment within defined procedures and practices to determine appropriate action.

Self-motivated team player

Completes assignments on-time and accurately

Displays commitment to quality and performs job functions to the best of his/her ability

Relate to others in a team setting.

Maintain positive attitude in a team environment.

Timeliness in completing assigned tasks.

Works entire assigned shift, including arriving on time.