TITLE: QC Microbiology Associate
LOCATION: Fremont, CA (onsite)
DURATION: 12 months+
SCHEDULE: Typically 8-5p Mon through Fri - periodic weekend/ holiday short shift (approx. 4 hr) work.
MUST HAVES:
1. Experience in EM and/or WFI sampling
2. Experience working in a regulated environment
3. Experience in GxP data reporting and documentations.
ASSOCIATE/ TECHNICIAN – QUALITY CONTROL
PURPOSE
Novo Nordisk, a global health care company, is committed to discovering and developing innovative medicines to help people living with diabetes lead longer, healthier lives. To support this, Novo Nordisk is conducting research on stem cell therapy. Stem cell research raises hopes for improved treatment of Type 1 Diabetes and for future treatments with cell transplantation therapy. This treatment could be offered to people with many different serious chronic diseases caused by the degeneration of specific cells, such as Type 1 Diabetes. Type 1 Diabetes is manifested by the selective destruction of the insulin-producing cells in the body, which leads to a life-long dependence on insulin injections to control blood sugar levels. It is usually diagnosed in children and young adults. Cell therapy may offer a better treatment by replacing the lost cells with new insulin-producing cells derived from stem cells, thus avoiding daily multiple insulin injections as well as numerous blood glucose tests. This treatment may also offer better blood glucose control, which is crucial to avoid late-stage complications such as blindness and kidney failure. In this project Novo Nordisk will generate new stem cell lines to be used in future cell therapies to treat Type 1 Diabetes, Parkinson's disease, and chronical heart failure.
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.
