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Piscataway

    Senior Quality Assurance Specialist - Piscataway, United States - Germer International - Pharmaceutical Recruiting

    Germer International - Pharmaceutical Recruiting
    Germer International - Pharmaceutical Recruiting Piscataway, United States

    3 weeks ago

    Default job background
    Pharmaceutical / Bio-tech
    Description

    Join a leading pharmaceutical company at the forefront of drug development, gearing up for exciting advancements in formulation development and early-stage manufacturing. They are seeking a skilled Senior QA Specialist to drive their business forward. Check out this opportunity to delve deeper into the details.

    Responsibilities:

    • Work closely with the formulation development team to ensure quality and compliance of early-stage manufacturing processes, covering preclinical, toxicology studies, phase I and II trials, and scale-up activities.
    • Offer hands-on guidance and support to operators, transferring expertise from the lab to manufacturing environments for various processes like hot melt extrusion, spray drying, emulsion, and suspension.
    • Act as a dedicated quality expert for manufacturing, utilizing your knowledge in sterile manufacturing environments to maintain regulatory compliance and industry standards.
    • Create and review batch records, SOPs, and deviations with precision, ensuring accuracy and compliance with relevant regulations and quality norms.
    • Be a proactive troubleshooter and action-taker, leading continuous improvement initiatives and addressing issues in real-time to uphold manufacturing efficiency and product excellence.

    Qualifications:

    • Hold a Bachelor's degree
    • Experience in pharmaceutical formulation development, with a solid grasp of early-stage manufacturing processes and technologies.
    • Demonstrated ability to effectively educate and convey complex technical concepts to team members and operators.
    • Thorough understanding of quality assurance principles and procedures, including experience in creating batch records, SOPs, and handling deviations.
    • Familiarity with sterile manufacturing settings and knowledge of regulatory standards in pharmaceutical manufacturing.
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