- Perform routine and non-routine GMP and non-GMP sampling and testing
- Perform routine Environmental monitoring, personnel monitoring sampling, and WFI sampling
- Analyze, report and compile data package for approval
- Collect data for periodic monitoring trend reports
- Write/ revise documentation such as SOPs, training materials, and other required documentation
- Review test records for completeness, accuracy, and to ensure cGMPs and Good Documentation Practices are followed
- Data entry and review in electronics systems (ie. LIMs or PEMs)
- Support OOS and OOT investigation
- Initiate deviations and support investigations to determine root cause and corrective actions
- Initiate Change Control for new and major updates to procedures
- Coordinate and collaborate with suppliers
- Support commissioning and validation activities for relevant equipment and/or methods, as needed
- Order, stock, and inventory supplies for the QC laboratory, as needed
- 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 Physical Requirements 0-10% overnight travel required. Able to Aseptically gown and enter clean room. Able to lift 25 lbs. Able to work flexible hours as required by the process. Qualifications
- Bachelor's Degree required, within Micobiology/Biology/Chemistry/Life Sciences or related field preferred
- 3+ years' relevant experience required (or 1 year with an advanced degree). Preferred within the Pharmaceutical/Biotech industry. Relevant experience is defined below:
- Experience with the application of cGMPs, USP/NF, EuPH., FDA guidelines and ICH guidelines with the pharmaceutical industry, required
- Experience writing standard operating procedures and other cGMP documentation, required
- Experience writing deviation and/ or change control, preferred
- Experience in aseptic conduct and technique, preferred
- Experience with sterile cleanroom gowning, preferred
- Experience with PCR assays, preferred
- 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 We commit to an inclusive recruitment process and equality of opportunity for all our job applicants. At Novo Nordisk we recognize that it is no longer good enough to aspire to be the best company in the world. We need to aspire to be the best company for the world and we know that this is only possible with talented employees with diverse perspectives, backgrounds and cultures. We are therefore committed to creating an inclusive culture that celebrates the diversity of our employees, the patients we serve and communities we operate in. Together, we're life changing. Novo Nordisk is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, protected veteran status or any other characteristic protected by local, state or federal laws, rules or regulations. If you are interested in applying to Novo Nordisk and need special assistance or an accommodation to apply, please call us at This contact is for accommodation requests only and cannot be used to inquire about the status of applications.
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Senior Associate - Fremont, United States - Novo Nordisk
Description
About the Department
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 and chronical heart failure. Are you ready to make a difference?
The Position
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 Senior Associate – 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, raw material and IPC testing, data entry and analysis, procuring and maintaining lab supplies. This role will also support method verification as assigned.
Relationships
Senior Associate - Quality Control will work at the Cell Therapy manufacture facility located in Fremont, CA. This position will report to a member of the Cell Therapy Leadership Team. Internal stakeholders include employees in Manufacturing, Quality Assurance, Quality Control, Facilities and Analytical Development at NN Fremont, employees at the Novo Nordisk Research Center Seattle, Inc. (NNRCSI) and Novo Nordisk Corporate office in Denmark.
Essential Functions
