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Assists in other duties relating to overall compliance within Quality and Compliance department, as requested. Minimum of 5 years’ experience inGCP regulated industry (i.e., Clinical Research Coordinator, Clinical Research Associate, or GCP Auditor.
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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. Maintains a strong understanding of regulations and guidance as they pertain to compliance; maintains knowledge relating to regulatory updates.
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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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Develop CAPA plans and contribute to resolution of audit findings independently. Understanding of how to plan, prepare andconduct GCP auditsindependently. Hands-on experience with clinical trial and pharmaceutical development preferred.
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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 inGlobal Health & Pharma’sinternational awards programs for the last three consecutive years.
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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. Reputation as emerging leader in field with sustained performance and accomplishment.
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Quality Review Auditor will be responsible to analyze collected audit data, identify trends for staff re-training and implementing corrective action plans in collaboration with Coordinated Care Management staff.
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Responsibilities include conducting random audits on a statistical percentage of all inbound/outbound shipments as determined by the Quality Program; inspecting all boxes selected to visually identify intricate garment details as they relate to quality; completely and accurately recording statistical data on the type and frequency of errors found; and reporting errors found to managers in a timely manner.
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As a Quality Assurance Auditor for Legal Records, the primary role is to ensure the accuracy, completeness, and compliance of legal records related to operations. Data Integrity: Identify and rectify discrepancies, errors, or omissions in legal records.
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The Supplier Quality Auditor supports qualification initiatives, continuous improvement, and regulatory compliance across all sites. The Supplier Quality Auditor ensures and promotes compliance through external auditing of company's suppliers; vendors/ laboratory services/service.
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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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KNOWLEDGE REQUIRED: Knowledge of Mortgage Compliance. Ensure all HMDA data input is accurate for LAR purposes. EXPERIENCE REQUIRED: 3 or more years’ experience in Mortgage loan Quality Control File auditing.
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Through questioning the status quo and collaborating cross-functionally, the Senior Quality Assurance Auditor is responsible for leading, planning, scheduling, performing, and reporting a range of GxP audits across all phases of Clinical Research.
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data quality compliance auditor jobs Title: quality auditor
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