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    Pharmacy Quality Control Specialist - Houston, United States - ReviveRX

    ReviveRX
    ReviveRX Houston, United States

    2 weeks ago

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    Description
    Job Summary:

    Join our forward-thinking team as a Quality Control Specialist, where your expertise will be pivotal in advancing our commitment to excellence within a cleanroom sterile environment. Your role will be critical in managing samples, overseeing Quality Record Events (QRE), spearheading investigations, and formulating effective Corrective and Preventive Action (CAPA) strategies. As a key player in our quality assurance framework, you will ensure our products and services not only comply with but surpass regulatory benchmarks and customer expectations.

    Core Responsibilities:

    Sample Management:
    • Employ expert aseptic techniques to collect samples throughout the sterile compounding process within a cleanroom setting.
    • Organize and manage samples with precision outside of the cleanroom.
    • Supervise the maintenance of equipment (e.g., incubators) to guarantee the integrity and timely analysis of sample incubation.
    Quality Records Events (QRE):
    • Direct the identification, documentation, and thorough analysis of QREs to enhance quality control measures.
    • Innovate and apply efficient processes for the prompt and accurate documentation of quality incidents.
    CAPA Plan Development and Implementation:
    • Craft and execute detailed CAPA plans to rectify identified quality concerns, ensuring robust preventive measures.
    • Lead cross-functional teams in the implementation of CAPA plans, ensuring widespread adherence and integration.
    • Conduct comprehensive follow-ups to assess and confirm the effectiveness of implemented CAPA strategies.
    Ideal Candidate Profile:
    • Demonstrable experience and proficiency in aseptic technique and sample management, ideally within the pharmaceutical or healthcare industry.
    • Prior experience working in sterile environments, especially within sterile cleanrooms in a 503a or 503b pharmacy setting, is highly desirable.
    • Deep knowledge of Good Manufacturing Practices (GMP), Good Distribution Practices (GDP), and other critical regulatory standards.
    • Exceptional analytical, problem-solving, and decision-making skills.
    • Strong interpersonal and communication abilities, with a track record of successful cross-departmental collaboration.
    • A meticulous and quality-driven approach, with an unwavering dedication to maintaining the highest standards of quality.
    This role offers a unique opportunity to make a significant impact on our company's commitment to quality and excellence. If you have a passion for quality control and a desire to contribute to a team that values precision, innovation, and collaboration, we encourage you to apply.
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