Quality Lab Technician

1 month ago


Fremont, United States GForce Life Sciences Full time

ASSOCIATE/ TECHNICIAN – QUALITY CONTROL

12 month contract

On-site in Fremont, CA

Must be able to work on a W2

The Associate/ Technician – Quality Control will perform day-to-day QC activities while ensuring accuracy, timeliness and in compliance with current cGMP and regulatory expectations of cell-based products. The day-to-day activities will include but not limited to sample collection/ preparation, data entry and reporting, procuring and maintaining lab supplies.

ESSENTIAL FUNCTIONS

• Perform routine Environmental monitoring, personnel monitoring sampling, and WFI sampling

• Perform data entry into electronic system and compile data package for approval

• Revise documentation such as SOPs, training materials, and other required documentation

• Coordinate for sample pick-up/ shipments

• Order, stock, and inventory supplies for the QC laboratory

• Support additional projects and assignments assigned by lead and reporting manager

• Performs all job duties and responsibilities in a compliant and ethical manner and in accordance with all applicable healthcare laws, regulations and industry codes

• Support additional projects assigned by reporting manager

QUALIFICATIONS

• Bachelor’s Degree required, within Microbiology/Biology/Chemistry/Life Sciences or related field preferred.

• Prior industry experience preferred.

Preferred within the Pharmaceutical/Biotech industry. Relevant experience is defined below.

o Experience with the application of cGMPs, USP/NF, EuPH., FDA guidelines and ICH guidelines with the pharmaceutical industry

o Experience writing standard operating procedures and other cGMP documentation

o Experience with Water and/or EM sampling

o Experience in aseptic conduct and technique

o Experience with sterile cleanroom gowning

• Excellent organizational and multi-tasking skills, attention to detail, and the ability to adapt to changing priorities.

• Ability to handle conflicts.

• Solutions oriented and good at making decisions under time pressure

• Excellent organizational and communication skills required.



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