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Lead the response to quality or compliance issues, including product recalls, regulatory actions, and customer complaints, ensuring timely and transparent communication with all stakeholders.
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The Infusion Outpatient Pharmacist will work within the HHCI free standing oncology infusion center; overseeing the daily operations of the Compounded Sterile Products (CSP) area; assists in meeting regulatory compliance; and monitors training and competency assessment and quality assurance/control.
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Oversee the KYC Quality Program ensuring that errors and observations from Quality Control (QC), Quality Assurance (QA), Compliance Monitoring & Testing, Internal Audit and Regulators are accurate and remediated in a timely fashion.
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The Quality Assurance Team is responsible for ensuring that Corporate Audit activities comply with internal policies and procedures, as well professional standards set forth by industry and regulatory institutions.
$115,600 - $154,000 a yearFull-timeExpandApply NowActive JobUpdated 1 month ago - UpvoteDownvoteShare Job
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Certified Internal Auditor (CIA), Certified Public Accountant (CPA), Certified Regulatory Compliance Manager (CRCM), or Certified Fraud Examiner (CFE) Executes quality assurance reviews of core audit activities i.e. audits, issues validation, audit plan documentation and coverage, and other special projects, using predefined attributes and challenge questions, relevant for the review type and in accordance with the QA strategy.
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Minimum 5 years of experience conducting Bank Secrecy Act /Anti-Money Laundering audits, Risk Management audits, Compliance audits or a combination. Subject matter expertise of BSA/AML and Fraud related risks with a focus on data, data quality, data flows and a solid business understanding of application of these risks within a large financial institution.
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Acts as Auditor-in-Charge (AIC) by overseeing audit testing and ensuring it is executed in a timely manner and conforms with quality standards, audit policies, and procedures. Should be able to independently draft quality reports and present results to senior audit management across the globe, and engage in discussions about risk and demonstrates QA and AML knowledge.
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Regulatory & Compliance Officer Responsible for assuring compliance with all food safety & regulatory matters, also for supporting the Director of Quality and Food Safety in developing, implementing, and enforcing Food Safety Programs for company including SQF program), oversees the plant SQF program to ensure certification is maintained.
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Serves as a primary point of contact within BSA for quality assurance reporting through the banks Enterprise Risk Management framework, including maintenance of control descriptions and test outcomes in the appropriate/associated risk software/tools.
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For internal use only: QA/QC Laboratory Supervisor; QA; QC; lab supervisor; QA/QC lab supervisor; QA/QC lab; quality control; quality assurance; quality; quality management; internal controls; SOP; lab quality control; lab quality; HIPAA; OSHA; CLIA; CAP; process improvement; compliance; MT; MLT; clinical lab; medical lab; core lab; core laboratory; CLS; ASCP; AMT; LIS; Lab Daq.
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As a key member of the Quality Assurance and Regulatory Compliance team, this role will support the regulatory needs of Dana-Farber's new inpatient cancer hospital and new collaboration with Beth Israel Deaconess Medical Center as that work ramps up.
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Establish and maintain a Cell Therapy Quality Management System (QMS) to ensure compliance with regulatory requirements (e.g., FDA, EMA, etc.) 15+ years of experience in quality assurance and quality control within the biopharmaceutical or cell therapy industry.
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Summary of position : Responsible for monitoring quality control/assurance requirements of all preservation preformed onboard commercial and US Navy vessel in accordance with established Navy regulations and industry standards or specific contractual requirements as defined in the Scope of Work. Collaborate with customer QA personnel on necessary aspects of the job.
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Reporting to the COO, The Vice President, GxP Quality Assurance is responsible for establishing and leading Aveo’s Quality Management System (QMS) operations and ensuring compliance with Local, State, Federal, and International regulations and standards associated with GXPs and Quality Systems in a fast-paced, primarily virtual development environment.
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Responsible for Quality System records associated with analytical testing (change control, lab investigations, OOS, deviations, and CAPAs) Recruit, train, and develop a team of Quality Control professionals as needed.
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