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Rocklin

    Quality Control Technician - Rocklin, United States - GTT, LLC

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    OTHER
    Description
    Quality Control Technician
    Contract Duration 12 Months
    Pay range - $23 to $25/hr


    Primary Objective of Position:


    Under supervision, the Quality Control (QC) Technician performs laboratory activities in the QC lab including inventory tracking, ordering maintenance, bioburden, slide filling, and IHC; completing required tasks based on QC schedule needs and following standard operating procedures (SOPs) involving basic laboratory techniques, calculations, material measurements, operation of laboratory equipment, and record-keeping as necessary; supports the day-to-day activities of the QC department while adhering to applicable regulatory requirements, and local and global Quality Management System (QMS).


    Essential Functions:
    Quality Control Technician performs paperwork preparation, bioburden, and all basic laboratory tasks
    Track inventory levels and order materials as required
    Use local ERP system to accurately document work where required
    Stock area inventories on a daily, weekly, and monthly basis
    Maintain lab cleanliness in compliance with cGMP requirements
    Maintain records and keep inventory updated
    Escalate non-conforming products to management, and participate in the investigation process
    Meet productivity standards and strive to increase productivity without sacrificing quality and safety
    Look for ways to improve and promote quality
    Demonstrate accuracy and thoroughness
    Manage time and priorities to meet deadlines
    Troubleshoot equipment problems
    Maintain knowledge of SOPs and GMP regulations and guidelines
    Maintain cGMP compliance
    Participate in various projects to improve efficiency or compliance
    Maintain and demonstrate a high level of personal and professional integrity and report any suspicious activity to laboratory management
    Quality Control Technician responds promptly to customer needs, solicit customer feedback to improve service, and meet commitments.
    Approach others in a tactful manner, react well under pressure, treat others with respect and consideration, and present a professional image in all business matters
    Meet productivity standards, and strive to increase productivity without sacrificing quality and safety
    Look for ways to improve and promote quality; demonstrate accuracy and thoroughness
    Observe safety procedures, report potentially unsafe conditions, and use equipment and materials properly
    Must be willing and able to work on weekends or extended hours as needed

    Follow regulatory and standard requirements as applicable to the site, i.e., MDSAP, ISO 13485, IVDR, and compliance with the site Quality Manual.

    Other duties as assigned or required by the business


    Required Knowledge, Skills & Abilities:
    General knowledge of FDA QSRs cGMP, and ISO 13485 or other related industry standards is required
    Knowledge of FDA QSRs cGMP, and ISO 13485 or other related industry standards is preferred
    Knowledge of SAP and/or SAP NEXT preferred
    Good oral and written communication skills
    Good interpersonal skills
    Good documentation skills

    Good math skills:
    able to add, subtract, multiply, and divide into all units of measure, using whole numbers, common fractions, and decimals; able to compute rate and percentage
    Ability to read, analyze, and interpret instructions, correspondence, policies, procedures
    Ability to write reports, correspondence, and procedures


    Required Education & Experience:
    Minimum AA/AS degree in a biological science or related field is required
    BA/BS degree in biological science or an equivalent life science degree is preferred
    Minimum two (2) years of experience in an FDA/ISO or other regulated environment is preferred
    Experience with calendaring, word processing, and spreadsheet software required; experience with Microsoft 365 (Word, Excel, PowerPoint) preferred


    Benefits:
    Medical, Vision, and Dental Insurance Plans
    401k Retirement Fund


    About The Company:


    Our client aspires to be the premier research-intensive biopharmaceutical company by using the power of leading-edge science to save and improve lives around the world.

    For more than 130 years, they have brought hope to humanity by developing important medicines and vaccines.

    Today, they are at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals.

    Our client fosters a diverse and inclusive global workforce and operates responsibly every day to enable a safe, sustainable, and healthy future for all people and communities.

    #gttnonit


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