Quality Assurance is responsible for developing and implementing a compliant and cost effective quality system that assures products and services are reliable, safe and effective. Demonstrates knowledge of quality systems and approaches. Demonstrates an understanding of the relevant regulations, standards and operating procedures. Demonstrates ability to perform investigations / root cause analysis and develop corrective actions. Demonstrates an understanding of the requirements and has the ability to perform gap assessments to those requirements. Demonstrates an understanding of quality concepts such as: cost of quality, analytical metrics and / or statistics, trending, quality planning, validation, CAPA and problem solving. Works cross-functionally and has the ability to interpret the requirements as well as educate and influence others on those requirements. Responsibilities include maintaining accurate and current Quality records, performing real-time QA review of batch documentation and other GMP related documents, issuance and reconciliation of product labels for production, performing AQL testing for visual inspection, understanding technical/release product issues and evaluating their potential impact on product quality and compliance, championing Quality, GMP compliance and EHS/Radiation Safety practices, networking across business and functional units to achieve positive outcomes, assisting Quality Management with FDA and other regulatory agency activities, advocating for the customer’s needs, taking actions to continually improve quality and safety in daily work, reporting errors timely and appropriately, and performing other job duties as assigned. Qualifications include a Bachelor's in science related field or equivalent work experience preferred, 2+ years’ experience in related field preferred, 2 years of relevant work experience working with 21 CFR 210, 211 in the FDA regulated industry preferred, understanding of cGMP/compliance requirements for cosmetic and pharmaceutical products, working knowledge of Microsoft Office Suite, Adobe editing software, and Document Management software, demonstrated ability to manage timelines and priorities, work independently, multi-task and focus attention to detail. The work environment is a radiopharmaceutical manufacturing facility with exposure to low amounts of radiation deemed safe by current standards, regulated by State and Federal agencies, with specific training and monitoring for radiation exposure. Noise levels are low to moderate.
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