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    Senior Quality Assurance Associate - Rockville, United States - Antech Diagnostics

    Antech Diagnostics
    Antech Diagnostics Rockville, United States

    4 weeks ago

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    Description


    We understand that the world we want tomorrow starts with how we do business today, and that's why we're inspired to make A Better World for Pets.

    Antech is comprised of a diverse team of individuals who are committed to each other's growth and development.

    Our culture is centered on our guiding philosophy, The Five Principles:
    Quality, Responsibility, Mutuality, Efficiency and Freedom.

    Today Antech is driving the future of pet health as part of Mars Science & Diagnostics, a family-owned company focused on veterinary care.

    Current Associates will need to apply through the internal career site.

    Please log into Workday and click on Menu or View All Apps, select the Jobs Hub app, then click the magnifying glass to Browse Jobs.

    Job Purpose/OverviewThe Senior Quality Assurance Associate acts as a manufacturing site quality assurance representative.

    General responsibilities include reviewing quality records/documents; interactions with other departments to ensure compliance with internal procedures and applicable external regulations; and customer inquiry/complaint monitoring and facilitation of resolution.

    Previous experience working in a regulated manufacturing environment is required.

    Candidates must have a high level of interpersonal communication skills and the ability to work effectively and courteously in a multifunctional, start-up environment.

    Essential Duties and ResponsibilitiesReview manufacturing records

    • for accuracy and compliance with internal procedures.
    Review and approve deviations and non conformances with approval authority as designated by management.
    Regularly provide quality assurance guidance to the site.
    Maintain quality assurance logs and provide reporting to sites as scheduled and/or requested.
    Conduct incoming material inspections and releases.
    Review and print labeling materials for production as needed.
    Involved with quality issues and actively pursue timely, compliant closure and documentation of all events and investigations.

    Act as the primary point of contact for customer inquiries and complaints, facilitate investigation, and ensure prompt resolution with customer.

    Apply change management utilizing a risk-based approach.
    Review and understand analytical data.
    Perform routine inventory transactions in MRP systems.
    Serve as a back-up for sales/purchasing system transactions.
    Participate in multi-functional project teams, as necessary.
    Perform other related work as assigned.

    Education and ExperienceBS in a relevant science or technical discipline.5+ years working in a regulated environment in a quality or regulatory capacity.

    Knowledge, Skills and AbilitiesComprehensive understanding of basic scientific principles and biotech manufacturing processes.
    Comprehensive understanding of and experience with GMP and ISO regulations.

    Able to communicate technical matters clearly and professionally while guiding teams to compliant, creative.solutions, Able to communicate clearly and firmly when noncompliant or potentially non-compliant situations are identified.

    Able to work in a fast-paced environment handling multiple priorities with attention to meeting deadlines while working effectively and efficiently.

    A willingness to think outside of the box and adapt industry best practices and trends to our small but growing business.

    Highly organized with exceptional written and verbal communication skills.

    Must be fluent in English (written and spoken).Ability to problem solve with several variables in a methodical and careful manner.

    Strong functional proficiency using Windows, Word, Excel, and PowerPoint as well as the ability to quickly learn various job-specific computer applications.

    Ability to work with colleagues, supervisors, vendors, and customers as needed.
    Ability to be flexible and adaptable, willingness to help when needed.
    Reliable attendance mandatory.
    Able to walk and stand for extended periods of time on a variety of hard surfaces.

    Ability to work in a warm, cold, or dry environment in a manufacturing production setting with exposure to working near moving mechanical parts.

    Working ConditionsThe associate is regularly required to apply manual dexterity, including hand/wrist flexibility, for computer keyboarding.

    The associate frequently is required to sit for extended periods of time, stand, walk, and reach with hands and arms.

    The associate is frequently required to hear and speak in order to use the telephone, make presentations and communicate with people in an office environment.

    The associate is occasionally required to sit and stoop, bend, kneel, or crouch. The associate must occasionally lift and/or move up to 15 pounds.
    The associate will primarily work in a typical office environment including the use of cubicles, computers and overhead lighting. Temperature extremes will be minimal to nonexistent. The noise level in the work environment is usually moderate. The associate will be required to use a computer, spreadsheets, data base management, email, and the Internet. The associate is frequently required to use a calculator; fax, copy machine, and phone system. The associate must occasionally use media equipment such as an overhead projector, PowerPoint, and Microsoft Teams. We are a rapidly growing, stable company with excellent advancement opportunity.

    We offer a great benefits package and associate pet health benefits too If you are passionate about animal healthcare, are motivated by making a difference we want to hear from youWe are proud to be an Equal Opportunity Employer - Veterans / Disabled.

    For a complete EEO statement please see our career page at Antech Careers
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