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    Quality Assurance Technician - San Diego, United States - Coneybeare LLC

    Coneybeare LLC
    Coneybeare LLC San Diego, United States

    2 days ago

    Default job background
    Full time
    Description
    BlSan 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 3rdparty 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.
    Minimum Qualifications:
    Education and Experience:
    • Degree: BS in Microbiology, Food Science / Technology or equivalent experience.
    • A minimum of 2-years process operations experience in a cell culture or food 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.
    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 or sterile processing experience
    • 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 Statistical Process Controls studies to ensure accuracy of data and analytical processes
    • Basic understanding of microbiological and chemistry testing procedures
    • Experienced with aseptic techniques
    • 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
    • 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.
    • 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
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