Quality Assurance Technician | BlueNalu, Inc.

BlueNalu, Inc. is a fast-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’s platform technology can produce a wide array of value-added seafood products, that are healthy for people, humane for animals, and sustainable for

the planet. Our products will contain no mercury, microplastics or other contaminants, and do not require genetic modification.

Job Summary:

Quality Assurance Technician will conduct routine Quality Assurance Checks, and related activities to ensure that the product meets food safety, quality, SQF, and regulatory requirements. This individual will work cross-functionally with R&D, Bioprocess Engineering, Quality, Operations, and other functional areas as needed to ensure specifications are met as set by the Quality Management Systems. In addition, the individual will manage and perform sampling and basic QC testing based on process and quality needs. This role will be a vital member of the Quality team and reports to the Quality Assurance Manager.

Essential Responsibilities:

  • Conduct routine Quality Assurance Checks to ensure the product and documentation meets food safety, compliance, and quality specifications.
  • Perform sanitation verification swabbing such as ATP, Allergen, and Environmental Monitoring
  • Perform audits including but not limited to:
    • Good Manufacturing Practices
    • Internal Audits
    • Pre-Operational Checks
    • Sanitation Verification Checks
  • Aseptic sampling of raw materials, in-process samples, and product and coordinating testing with a 3rd party lab.
  • Identifying and reporting deviations
  • Calibrating and cleaning testing equipment
  • Provide guidance to production team for product safety and quality related issues
  • Support verification activities related to SQF such as but not limited to:
    • Program Verification and Validation Activities
    • Sanitation Log Verifications
    • Batch Record Verifications
  • Assist QA management with special projects or other duties as assigned.

Jobs Supervised (by title):

  • Quality Assurance Manager

Travel: None

Minimum Qualifications:

  1. Education and Experience:
    • Degree: BS in Microbiology, Food Science / Technology or equivalent experience.
    • A minimum of 2-years process operations experience in a manufacturing facility subject to GMP regulations
    • Experience generating quality system and operations related documentation in a GMP environment.
    • Expertise with Microsoft Word, Excel, Adobe Acrobat, and PowerPoint, to perform critical job functions.
    • Experience with cell culture strongly preferred.
    • Legally authorized to work in the United States.
    • Local candidates preferred
  2. Knowledge, Skills and Abilities:
    • Must be adaptable and flexible
    • Must be organized, detailed oriented, and analytical
    • Strong organization skills, with the ability to organize, plan, prioritize work, and manage multiple projects effectively, within agreed upon timelines.
    • Strong interpersonal skills, with the ability to positively interface with individuals at all levels of the organization.
    • Excellent communication / presentation skills
    • Basic HACCP knowledge
    • Practical knowledge of FDA regulations including GMP and GDP
    • Ability to read equipment/instrumentation operations manuals
    • Follow, understand, and write/revise Standard Operating Procedures
    • Ability to think critically to determine root cause analysis for deviations
    • Corrective actions and preventative knowledge and understanding
    • Ability to work independently
    • Excellent recordkeeping / documentation skills
    • Perform data audits, including SPC studies to ensure accuracy of data and analytical processes
    • Basic understanding of microbiological and chemistry testing procedures
    • Basic understanding of laboratory testing equipment
    • Understanding of current laws and regulations related to food manufacturing
    • Proficient with Microsoft Office (Word, Excel, Access, Outlook, PowerPoint, Smartsheet, Visio)
    • Familiar with Cleaning-In-Place (CIP) and Sterilization-In-Place(SIP) systems and procedures preferable
    • Strong written and verbal communication skills
    • Fluent in English

Nonessential Qualifications:

  • HACCP Training
  • PCQI Training
  • SQF Training

Materials and Equipment Directly Used:

  • Office machinery including computers, printers, copiers, etc.
  • Microsoft Office Suite and other computer systems.
  • Basic lab equipment such as pH meters, Near Infrared Spectrometer (NIR), etc.

Working Environment / Physical Demands:

The physical demands and work environment characteristics described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Physical Demands:

  • Ability to work in noisy, dusty, wet, hot or cold environments for extended periods of time
  • Requires prolonged sitting and standing, bending, stooping and climbing
  • Requires eye-hand coordination and manual dexterity sufficient to operate a keyboard, photocopier, telephone, calculator, and laboratory equipment
  • Requires normal range of hearing and vision (including colors) to record, prepare and communicate appropriate reports and laboratory results
  • Requires lifting up to 50 pounds. Requires exposure to machines, chemicals and solvents
  • No makeup, or jewelry can be worn when working in cleanroom environments
  • Required flexibility to meet gowning procedures for cleanroom environments
  • Ability to work 8 hours shifts including overtime, along with weekends and evenings

Work Environment:

  • Partially remote until facility opens.
  • Must understand vague and implicit instructions and react favorably in all work situations.
  • Must be mentally adaptable and flexible in dealing with a variety of people.
  • Emotional stability and personal maturity are important attributes in this position.
  • Must be able to resolve problems, handle conflict and make decisions under pressure.
  • Ability to give, to receive, and analyze information, formulate work plans and prepare written materials and articulate goals and action plans.
  • Must understand people and be able to communicate effectively.
  • Ability to do basic math calculations, input data into a computer and analyze data is required.
  • Ability to work with and directly handle products containing Major US Allergens and sensitizing agents such as fish, soy, and shellfish.

Additional Information

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, Inc. 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’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.

To learn more, visit: www.bluenalu.com

To apply for this position, visit www.bluenalu.com/careers

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