Overview
Cell Therapy QC Microbiology Analyst Jobs in Portsmouth, New Hampshire, USA at Lonza Group Ltd.
Cell Therapy QC Microbiology Analyst
Apply locations US – Portsmouth, NH time type Full time posted on Posted 2 Days Ago job requisition R66205
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, preferably in Microbiology, Biochemistry or Related Science field.
2+ years industry experience, preferably in a cGMP environment.
Use of Microsoft Suite (Word, Excel, PowerPoint).
Use of Laboratory computer systems.
Potential previous use of GMP Quality Systems such as Track Wise, 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.
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Title: Cell Therapy QC Microbiology Analyst
Company: Lonza Group Ltd.
Location: Portsmouth, New Hampshire, USA
Category: Healthcare (Data Scientist), Quality Assurance – QA/QC (Data Analyst)
