Celltex: Quality Control Associate

Job Description:

Job Title: Quality Control Associate Status: Full time
Department: Operations – Quality Control Reports to: Quality Control Manager
Job Purpose:

The Quality Control Associate (QC Associate) is a vital position in the quality unit operations of Celltex’s laboratory services.  The primary responsibility of the QC Associate is to test and inspect the environment, materials and samples to ensure the quality of banked and outgoing products.

Job Duties:

·         Understand Celltex Standard Operating Procedures (SOPs) and apply them as required

·         Understand cGMP/GLP guidelines and 21 CFR Part 11 procedures

·         Writing/revision of SOPs

·         Perform aseptic handling, sampling and testing of cell therapy products

·         Perform sterility testing of outgoing products, incoming specimens, reagents, cell cultures and media to ensure the absence of microbial growth

·         Read and document results of ongoing sterility tests

·         Perform endotoxin testing of final products to ensure current levels are within the established acceptance criteria

·         Perform mycoplasma testing of outgoing products, incoming specimens, cell cultures, and media to ensure current levels are within the established acceptance criteria

·         Determine cell counts and cell viability for outgoing products

·         Log, document, and verify the receipt of incoming specimens

·         Perform testing of incoming products

·         Perform environmental sampling and testing to determine the sterility and cleanliness of work areas

·         Document and maintain LUMACs on assigned equipment as per SOPs

·         Participate in Quality Control validations as needed

·         Maintain the cleanliness of clean rooms and designated areas, as assigned

·         Attend and participate in group and project meetings

·         Complete all assigned tasks on time per team schedules

·         Identify and report problems to the QC Manager

·         Report out-of-specification and/or non-conformances to the QC Manager

·         Demonstrate cross departmental cooperation for testing needs

Skills/ Qualifications:

Detail oriented and organized with the ability to accurately record data and document all activities, team player, excellent writing and communication skills, ability to multi-task, and demonstrate aseptic technique. Ability to perform sterility, endotoxin, mycoplasma, cell counting (manual and automated), viability, and qPCR.  Knowledge of standard MS office suite.

Education/Experience:                                                                                                                                                                  Bachelor’s degree in biology or microbiology.  Familiarity with microbiology laboratory techniques.  At least 1 year cGMP laboratory experience is needed.  Fundamental knowledge of regulatory requirements, such as cGMP regulations is a plus.

Quality Control, Operations, Laboratory

 

Leave A Reply:

(optional field)

No comments yet.