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Quality Control Microbiology Associate I

Company: Novo Nordisk
Location: Fremont
Posted on: May 3, 2021

Job 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

This position will perform a variety of procedures to support a manufacturing environment in compliance with Current Good Manufacturing Practice (cGMP) regulations. These activities will include coordinating with manufacturing to take microbial and particulate samples, organizing and conducting testing, creating and maintaining standards, and conduct investigations for the Environmental Monitoring (EM) and microbial program. This position will also perform Quality Control (QC) testing in various microbiology techniques, including growing and assessing microbial organisms, bioburden, PCR for microbes and mycoplasma and endotoxin testing to support in process controls and product release.

Relationships

The Quality Control (QC) Microbiology Associate I will work at the Stem Cell manufacture facility located in Fremont, California. The QC Microbiology Associate will report to a member of the Stem Cell Manufacture Leadership Team. Internal stakeholders include employees in Research & Development (R&D) in Novo Nordisk A/S, employees of UCSF, and employees at the Novo Nordisk Research Center Seattle, Inc. (NNRCSI) and Novo Nordisk Quality.

Essential Functions

+ Conduct viable and non-viable EM Sampling in the GMP cleanrooms including the manufacturing suites and surrounding shared areas

+ Review EM records for completeness, accuracy, and to ensure cGMPs and Good Documentation Practices are followed

+ Write and/or revise master EM records, Standard Operating Procedures (SOPs), training materials, and other required documentation

+ Provide support for commissioning and validation activities in addition to other facility start-up activities, as needed

+ Data entry and review in PEMS (electronic EM database)

+ Perform microbial testing to support in process controls and product release, including PCR, bioburden, endotoxin, and general microbial growth assays

+ Initiate deviations as needed and take part in investigations

+ Order, stock, and inventory supplies for the EM program and QC laboratory as needed

+ Coordinate EM testing results with an outside laboratory and UCSF employees as needed

+ Assist in conducting investigations for EM excursions including determining root cause and developing corrective and preventative actions

+ Support inspections from Authorities and internal audits

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

+ Proactively take on additional work to support the manufacturing team with all aspects of the process

Physical Requirements

0-10% overnight travel required. Must be able to gown aseptically.

Qualifications

+ Associates degree required, in the life sciences field preferred. Bachelors is preferred

+ 2+ years' relevant experience, Advanced degree may be substituted for experience

+ Relevant experience includes some combination of:

+ Executing viable and non-viable sampling in a cleanroom environment using air samplers, particle counters, swabs, and contact plates

+ Experience and ability to work in sterile cleanroom gowning

+ Knowledge of current Good Manufacturing Practices

+ Familiarity with regulatory requirements for environmental monitoring of cleanroom areas

+ Knowledge and experience with aseptic conduct and technique preferred

+ Experience with PCR assays preferred

+ Ability to recognize problems and recommend solutions to problems based on technical understanding of testing techniques

+ Good organizational and communication skills

+ Ability and desire to support the team with additional tasks

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 1-855-411-5290. This contact is for accommodation requests only and cannot be used to inquire about the status of applications.

Keywords: Novo Nordisk, Fremont , Quality Control Microbiology Associate I, Other , Fremont, California

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