BlueNalu, Inc. is a rapidly growing, San Diego-based company that is pioneering the production of seafood products derived directly from fish cells. Using proprietary cell biology techniques and engineering processes, BlueNalu#39;s platform technology can produce a wide array of value-added seafood products, that are healthy for people, humane for sea life, and sustainable for our planet. Our products will be great tasting, trusted, safe, and free of mercury and environmental contaminants. BlueNalu has achieved considerable strategic, technical and operational milestones since its formal launch over two years ago, and it is now preparing for regulatory clearance and market launch in the US, that are both anticipated to occur during the second half of 2021.
As Quality Assurance Manager, you will be responsible for providing operational direction, implementation, and execution of all programs to ensure the safety, quality, and regulatory compliance of BlueNalu#39;s cell-based products. You will demonstrate strong leadership skills, be highly collaborative, consistently proactive, engaged, and persistent in finding solutions and new ideas to achieve BlueNalu#39;s company objectives. This position#39;s initial focus will be on the scale-up and commercialization of our first cell-based seafood product. This will include food safety and quality relationships with government agencies, including the US FDA and CAFDB.
The Quality Assurance Manager will be based at the company#39;s office(s) in San Diego, CA. The Quality Assurance Manager will work with our internal teams to coordinate the implementation of and adherence to all necessary quality programs at the manufacturing facility. Responsibilities will include the following:
- Responsible for the implementation and continual update of BlueNalu’s Quality Management System to ensure full compliance with regulatory requirements and standards
- Oversee prerequisite food safety programs, including pest control, sanitation, allergen control, foreign material control, etc.
- Drive food safety culture through employee engagement, training, and other activities to influence and motivate food safe behavior
- Ensure Food Safety programs and systems comply with all applicable food regulations and standards
- Monitor performance against BlueNalu#39;s procedures, product specifications, and relevant Key Performance Indicators (KPIs)
- Manage the Corrective Action process, including review, trending, and on-going adherence to all CAPAs related to food safety and quality
- Work closely with the Research and Development and Bioprocessing teams to ensure food safety requirements and quality standards are incorporated into the development process
- Effectively identify food safety and quality risks in the product or process development process and communicate risks to cross-functional stakeholders while providing solutions to mitigate those risks
- Provide support during plant trials and production runs for product launches
- Ensure that new BlueNalu suppliers are successfully on-boarded and qualified prior to commercial production; develop and coordinate any required testing, validation, and specific requirements as needed for supplier qualification-related activities
- Drive continuous improvement efforts with manufacturing suppliers and internal cross-functional stakeholders to ensure ongoing development and improvements to established quality programs
- Act as a subject matter expert for internal and external stakeholders as it relates to food safety and quality
- In-depth knowledge of food microbiology, product sampling plans, and environmental monitoring programs
- Knowledge of statistical applications including process control, data analysis, sampling, and experimental design
- In-depth knowledge of FDA FSMA regulations and SQF Standard
- Technical writing skills with experience writing food safety and quality-related policies, procedures, and work instructions.
- Internal and external auditing, risk identification, and mitigation development
- Ability to design and deliver comprehensive employee food safety and quality training
- Confidence as a food safety expert to make business and quality risk-based decisions and recommendations based on scientific, regulatory, and quality evidence
- Systematic approach to problem solving and collaboration across disciplines
- Accountable and highly adaptable while maintaining high quality and food safety standards
- Excellent communication skills; ability to seamlessly work with cross-functional teams
- Coaching, mentoring, and talent development
Qualifications & Experience
- B.S. or M.S. in Food Science, Microbiology, or similar degree with 5+ years of progressive food industry experience in food safety and quality assurance.
- Minimum 3-5 years of experience managing an FDA regulated facility food safety and quality program which includes quality systems design, management, and implementation.
- Certified as a Preventive Controls Qualified Individual (PCQI)
- Qualified Safe Quality Foods (SQF) Practitioner
- Experience with food safety culture planning and implementation
- Experience deploying and/or managing automated systems for documents and data
- Experience with environmental microbiology and monitoring
- Better Process Control School and/or Seafood HACCP certification is preferred
- Experience with cell culture, starter culture and/or fermented products is preferred
BlueNalu, Inc. provides an attractive compensation and benefits package. All applicants must be authorized to work in the US, and willing and able to work a flexible work schedule to meet the needs of the Company. BlueNalu is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all employees.
This is an excellent opportunity to join a small but quickly growing company where everybody#39;s contribution is equally important. BlueNalu is seeking team players that are driven, focused, creative, proactive and productive, with excellent written and verbal communication skills, and excellent interpersonal and organizational skills. We are also seeking team members that enjoy and thrive in the atmosphere of a very fast-paced entrepreneurial environment, have a good sense of humor, and are personally motivated to make a difference to humanity and our planet.
Additional information about BlueNalu can be found on our website at www.bluenalu.com