• Specialist, Quality Assurance
• R&D Scientist
• Senior Manufacturing Associate/Manufacturing Associate Needed (Hayward / Castro Valley)
Specialist, Quality AssuranceThe position of Specialist, Quality Assurance reports to the Director, Quality Assurance, and has responsibility for implementing the company’s quality system.
- Administer and maintain quality assurance procedures and activities required to ensure that the company’s processes and products are in compliance with applicable quality standards and requirements
- Employ quality assurance methodologies in support of manufacturing and regulatory functions
- Assist in identifying quality assurance metrics; analyze and report trends to management
- Perform batch record review
- Manage the nonconforming materials program
- Support the product complaint and CAPA sub systems
- Administer document approvals and change controls
- Participate in all stages of design development, Verification &Validation testing and design control activities, ensuring quality assurance considerations and requirements are met
- Assist in Risk Management activities, FMEAs and ensure compliance to risk standards and regulations
- Review Design History records for completeness and adequacy
- Assist in preparation for and conducting of regulatory agency inspections
- Perform other tasks as assigned
- Bachelor’s Degree in life sciences
- Minimum two years of experience in a quality assurance function with IVD or Medical Device products
- Current knowledge of IVD or Medical Device regulatory requirements, including 21 CFR 820, ISO 13485 and ISO 14971
- Ability to write policies and SOPs as well as assist others in writing policies and SOPs.
- Experience in maintaining a document control system, preferably involving reagents, instrumentation and consumables. Experience with an electronic document control system desired
- Experience developing and executing quality plans to support IVD products desired
- Ability to ensure compliance with regulations and procedures
- Ability to communicate effectively internally and externally. Strong verbal and written communication skills as well as strong listening skills
Novodiax is a California corporation located in Hayward, CA, focusing on development of tissue based diagnostics. Novodiax has successfully developed a proprietary "Direct IHC" technology and has further identified two unique applications, each targeting an unmet medical or diagnostic need, each creating a potentially huge market. Novodiax is growing and our R&D Department is currently in expanding and looking for an R&D Scientist.
Novodiax is an In-Vitro Diagnostics company and plans to expand the business. We are seeking a self-motivated, energetic, detail-oriented PhD level Scientist with expertise in immunology, molecular biology to join a fast-paced working environment. He or she will work closely with discovery scientists to investigate exploratory biomarkers based on target pathway biology and preclinical models, and translate findings into clinical assays.
The primary focus of this position will be to understand target biology, explore new technologies, and develop and optimize immune assays for use with biological samples (serum, tissue, PBMC). The individual will also be responsible to develop antibodies against tumor biomarkers, including mouse monoclonal antibody, rabbit polyclonal and monoclonal antibodies. The individual will also work with other scientists to generate recombinant antibodies in mammalian cell and yeast systems.
NOVODIAX provides the Equal Employment Opportunity for any applicants/potential candidate to apply for this job position, and also encourage the Minorities/Women/Veterans/Disabled personnel to apply for this job position.
- M.S. or Ph.D. in Immunology or molecular biology with a minimum of 2 – 3 years’ relevant experience. Experience in working with human biological samples is preferred.
- Must have hands-on experience in tissue culture and standard immune assays as well as molecular biology techniques including ELISA, Western blot, electrophoresis, etc.
- Experience in development of recombinant monoclonal antibodies is preferred.
- Experience in gene expression in yeast system is a plus.
- Working effectively in cross-functional team, the ability to multi-task on different projects, and efficient time management skills
- Must have excellent verbal and written communication skills to keep documentation and regularly summarize data to present results to team members.
Senior Manufacturing Associate/Manufacturing Associate Needed (Hayward / Castro Valley)
Senior Manufacturing Associate/Manufacturing Associate Needed
Novodiax is a California corporation located in Hayward, CA, focusing on development of tissue based diagnostics. Novodiax has successfully developed a proprietary "Direct IHC" technology and has further identified two unique applications, each targeting an unmet medical or diagnostic need, each creating a potentially huge market. Novodiax is growing and our Manufacturing Department is currently in expansion and looking for Senior Manufacturing Associates.
We have an opportunity for a talented and highly motivated Senior Manufacturing Associate/Manufacturing Associate to join our manufacturing team. The successful candidate will be primarily responsible for daily manufacturing work in compliance with cGMP and ISO 13485 practices. The work will include reagent formulation, antibody purification and conjugation, reagent aliquoting, labeling and packaging, quality control testing using immunohistochemistry (IHC), ELISA, gel filtration chromatography.
Who you are:
In hiring new employees, we look for people who are also inspired by our mission and who would fit in well with the collaborative, rigorous and entrepreneurial spirit of the company culture. Because we know that employees are critical to our success in bringing novel diagnostics to patients, we are dedicated to remaining a great place to work and to providing employees with programs, services and benefits that allow them to bring the best to the business and to their personal lives.
- B.S. in biology or related discipline, with five (for Senior Manufacturing Associate) or two (Manufacturing Associate) more years of working experience in in vitro diagnostic product manufacturing is required.
- Expertise in histology/pathology techniques such as tissue fixation, embedding, sectioning, IHC staining is preferred.
- Must be motivated, thoughtful and capable of working both independently and in a collaborative team setting. Strong problem solving, organizational and communication skills are also required.