Cell Therapy QC Microbiology Analyst (Biotech)
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.
