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.
By applying, you consent to your information being transmitted by Jooble to the Employer, as data controller, through the Employer’s data processor SonicJobs.
See Sonicjobs Privacy Policy at and Terms & Conditions at and SonicJobs Privacy Policy at and Terms of Use at
...successful resolutions or take cases to trial as a first chair attorney. AAG IV-Vs also serve vital roles on larger teams handling... ...state agency making a positive difference in the lives of Texans. Assistant Attorneys General (AAGs) experience the challenge and honor of...
...Join to apply for the Profee Medical Coder Complex Neurology role at Banner Health 2 days... ...team. Our leaders and coders work in a remote environment. Even though we work remotely... .... Certified Coder, Medical Coders and billing professionals wanted, part time, full time...
...including toilets, urinals, lavatories, flush valves, sinks, drains, water heaters, piping, and sump pumps. Prepare, prime and paint building interior and exterior surfaces and perform general handyman tasks to maintain buildings. Completes special tasks that...
...Light Health is looking for a licensed Nurse Practitioner or Physician Assistant with certification in Psychiatry to work virtually and in... ...services with offices throughout Colorado and New Mexico. Psychiatric experience is preferred. You will be joining a team of providers...
...Shift: 10 hours, days ~ Employment Type: Travel Shift: 7a-530P - 4/ 10 hour shifts a week\nWeekend/On Call Requirement: One weekend on call a month for a total of 36 hours 24 hours on Saturday and 12 hours on Sunday\nCertification/Licensure:\nCurrent licensure...