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Quality Assurance Operations Specialist III

Massachusetts General Hospital

This is a Full-time position in Boston, GA posted December 2, 2020.

GENERAL SUMMARY/ OVERVIEW STATEMENT:With little guidance from the Director of Clinical Operations, the Quality Assurance (QA) Operations Specialist provides ongoing daily records management support (paper and electronic) for therapeutic development projects.The QA works with cross-functional development teams to ensure accurate and timely management of internal and sponsor standard operating procedures.

With a focus on inspection readiness, the QA monitors compliance with company process and regulations and designated clinical activities in preparation for regulatory inspection and audits.PRINCIPAL DUTIES AND RESPONSIBILITIES:Key Responsibilities:* Manage and maintain standard operation procedure and quality system documents for sponsor or FDA inspection; support quality objectives through the preparation, issuance, continuous review, revision, identification of areas for procedure(s) consolidation and eventual retirement of SOPs and related guidelines* Coordinate training activities and ensuring that all required personnel are aware and trained in the requirements of the established Quality System, including SOPs and related guidelines* Ensure that all third party operations used for any or all of the conduct of clinical studies, non-clinical studies and manufacturing operations adhere to the requirements of the Quality system, contractual requirements, SOPs and guidelines.* Implement a system for conducting internal quality system audits and evaluation of third-party operations providing products or services.* Provide on-going deviation management to capture non-compliances detected outside audits or inspections and verifying the implementation of CAPA.* During FDA audits, function as primary source of document retrieval to ensure correct and complete documents are provided to auditors* Conduct an annual review of the quality system and report findings of that annual review in the Quality Annual Report.* Maintain revision control and tracking for controlled documentsWORKING CONDITIONS:Normal working conditionsSUPERVISORY RESPONSIBILITY:May serve as team leader to Documentation Specialists, coordinators and administrative staffFISCAL RESPONSIBILITY:Tracking invoices and reconciling invoices with budget and /or contractsQUALIFICATIONS: EDUCATION/EXPERIENCE/CERTUFUCATION* Bachelor’s Degree required* Masters Degree preferred* GCP certification* 3 years’ directly related and progressively more responsible experience requiredSKILLS/ ABILITIES/ COMPETENCIES REQUIRED* Ability to complete the preparation and submission of documents using regulatory/document management systems* Ability to work in multidisciplinary project teams with knowledge of the drug development process and drug regulation as relates to regulatory submission operations* Knowledge of and experience in document-level formatting and publishing* Understanding of FDA and ICH specifications* Detailed knowledge of the pharmaceutical industry and regulatory documents* Ability to work independently (able to prioritize tasks, deadline oriented, good organizational and problem-solving skills, follow-up skills) with accurate and meticulous attention to detail* Detailed understanding of clinical trial management from a sponsor perspective* Proficiency with standard business software including Microsoft Word, Excel, and PowerPoint

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