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Expertise within CROs and scientific and clinical data/ terminology, and the drug development process. MMS is an innovative, data focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.
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Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards.
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Monitor vendors and clinical investigator sites to ensure processes are followed and quality is maintained independently. Assists in other duties relating to overall compliance within Quality and Compliance department, as requested.
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Requirements:College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years’ experience in GCP regulated industry if not a college graduateMinimum of 5 years’ experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.
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Minimum of 5 years' experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.) Minimum of 5 years' experience in GCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.
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College graduate in scientific, medical, clinical discipline or related experience, Masters preferred; or minimum of 7 years experience in GCP regulated industry if not a college graduate. Experience in reviewing and editing QMS related documents, i.e., SOPs, Work Practices, Forms, Training Materials, etc.
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With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years.
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Develop CAPA plans and contribute to resolution of audit findings independently. Understanding of how to plan, prepare and conduct GCP audits independently. Hands-on experience with clinical trial and pharmaceutical development preferred.
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Must be willing to travel up to 75% of the time for audits within the US and potential travel to Canada. Proficient with 21 CFR Part 11, FDA, and GxP requirements. Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates.
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Job Specific Skills:Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates. Reputation as emerging leader in field with sustained performance and accomplishment.
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Proficient in authoring and managing audit documents independently. Expert knowledge of scientific principles and concepts. Good communication skills and willingness to work with others to clearly understand needs and solve problems.
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Job Requirements Bachelor's degree in business administration or a related field (OR equivalent job experience) Prior experience with data and document management Computer proficiency and data entry skills Thorough understanding of relevant regulatory frameworks and agencies, as well as compliance best practices Be willing to get Certified Records Analyst (CRA) and/or Certified Information Professional (CIP) certification.
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For more information, visitor follow MMS on. Good organizational and communication skills. Excellent problem-solving skills. Proficiency with MS Office applications.
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Good organizational and communication skills. Excellent problem-solving skills. Proficiency with MS Office applications. For more information, visit www. mmsholdings.com or follow MMS on LinkedIn.
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For more information, visit. Powered by JazzHR.
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data quality jobs Title: quality auditor specialist
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