NOI Quality Investigator: Root Cause & CAPA
Socket.dev
Amneal seeks an NOI Investigations Specialist to lead investigations into aberrant events affecting product quality, guiding conclusions and CAPAs. You will perform interviews, root cause analyses and documentation to support timely regulatory submissions and batch releases. You will apply FMEA, 5 Why and other tools, write clear reports, and recommend quality improvements while ensuring GMP compliance, safety, and adherence to company policies across markets. #J-18808-Ljbffr Socket.dev
- Amneal Pharmaceuticals seeks an NOI Investigations Specialist to lead investigations into aberrant events affecting product quality and shelf life. You will gather facts, determine root causes, and define corrective actions to prevent recurrence, ensuring documentation...Quality
- ...Brookhaven, NY is seeking a Senior NOI Investigations Specialist to perform... ...aberrant events affecting product quality and release. You will interview, analyze root causes using FMEA/5 Whys, and prepare... ...scrutiny. Ensure GMP compliance and CAPA effectiveness while supporting...Quality
- ...LLC in New York is seeking an NOI Investigations Specialist to perform... ...aberrant events affecting product quality and release decisions. You... ...will conduct interviews, apply root cause analysis tools, and prepare... ...timely ANDA submissions, CAPA effectiveness reviews, and ensuring...Quality
- American Regent, Inc. is seeking a QA Senior Specialist - CAPA to ensure corrective and preventive actions and their effectiveness checks... ...departments and supports SNCR processes, regulatory audits, and Quality Council activities. The successful candidate will drive CAPA...Quality
- ...and system risks. Actively participate in root cause analysis (RCA) sessions and collaborate... ...Corrective and Preventive Actions (CAPAs) Assist with risk assessments of new and... ...change control. Prepare KPIs in support of quality reporting to management. Assist in other...QualityPermanent employmentContract workLocal area
$50k - $70k
Are you a detail-oriented Quality Inspector ready to step into a high-impact... ...logs. Non-Conformance & Root Cause Analysis: Issue Non-Conformance... ...lead Corrective/Preventive Action (CAPA) and Material Review Board (MRB) investigations. Calibration & Auditing: Manage...QualityPermanent employmentTemporary workWork experience placementShift work$125k - $140k
...the Factory Manager, the Manager, Facility Quality plays a key role in ensuring the... ...cGMP and SOP records. Leads and/or supports investigations through Root Cause Analysis and effective Corrective and Preventive Action (CAPA). Evaluate data using statistical tools....QualityWork at office- American Regent, Inc. is seeking a high-level Quality leader reporting to the Senior Director of Quality, guiding the quality management... ...improvement. You will drive KPI-based quality programs, manage deviation/ CAPA processes, and collaborate with Production, Regulatory Affairs,...Quality
$20.27 - $26.7 per hour
.... And our success allows Maharam to support causes that align with our values, so we can build... ...future for everyone. A support role on our Quality Assurance team across our three textiles brands. Responsible for investigating and processing quality related claims, entering...QualityTemporary workFor contractors- ...A leading healthcare company in Bayport, NY is seeking a Quality Manager to ensure adherence to quality system standards. This role involves leading the Quality Assurance team, maintaining compliance with FDA regulations, and managing quality systems. Ideal candidates...Quality
$275k - $285k
...pharmaceutical manufacturer in Shirley, NY. We are seeking a Sr. Director Quality Affairs to provide strategic leadership across site-wide... ...leadership for site Quality Management Systems, including Dev, CAPA, Change Control, Document Control, and batch release oversight....QualityPermanent employmentTemporary workWork experience placement- ...include aerospace and defense, factory automation, air and water quality environmental monitoring, electronics design and development,... ...documentation. The technician also contributes to internal root‐cause analysis and corrective‐action activities to support continuous...QualityMinimum wageWork experience placementWork at officeLocal area
$110k - $125k
...Lyophilization, depyrogenation and root cause analysis. Essential... ...and facilitating investigations to resolve process deviations... ...performance indicators—including quality, yield, throughput, cycle time... ...analysis, and drive effective CAPA implementation. Contribute...QualityFull timeLocal area- Supervisor, Quality Assurance - 1st Shift Monday to Friday 1 week ago Be among the first... ...validation & qualification studies, performs investigations and other assignments as required.... ...Corrective Actions and Preventative Actions (CAPA) through effective quality management...QualityHourly payFull timeWork at officeLocal areaAll shiftsMonday to FridayFlexible hoursShift workDay shift
- FLSA STATUS: Salary/Exempt DEPARTMENT: Quality SUPERVISOR: Quality Manager DIRECT REPORTS: No Position Summary Power Connector, LLC... ...Request, and notify Material Review Board for disposition Identify root causes and applicable corrective actions related to quality issues...Quality
$82k - $110k
...Engineering, Manufacturing, Quality, vendors, and contractors; documents... ...resolution, change control, CAPA, and continuous improvement.... ..., and supports their investigation and resolution. Assists with... ...Participates in investigations, root-cause analysis, data review, deviation...QualityFull timeFor contractorsLocal area$105k - $115k
The Sr. Quality Management Systems Specialist provides coordination and reporting that includes data... ...reporting. Additionally, supports preliminary investigations and prepares a summary of the findings to support NOIs, CAPAs, Complaints and other Quality related activities...QualityFlexible hours- ...process and QA best practices, process and guidelines for high quality releases. Execute various testing activities such as... ...Performance testing. Provides accurate problem identification, root cause analysis, ticket documentation and resolution. Identify dependencies...QualityWork experience placement3 days per week
- ...Quality Assurance Engineer IAs the Quality Assurance Engineer I, you support the Quality... ...cross-functional teams to identify, investigate, and resolve quality issues while developing... ...on factory non-conformances, perform root cause analysis with guidance, and assist in...QualityFor contractors
- ...Specialist, Aseptic Manufacturing Oversight to ensure GMP compliance and real-time quality monitoring in aseptic processes. You will oversee APA practices, review video footage, and support training, CAPA activities, and trend analysis across operations. The role requires a...Quality
$117.9k - $137k
...signatory authority and accountability for quality/compliance matters within the scope of... ...and confirmation of appropriate investigation and corrective action.Lead and support lifecycle... ...of deviation investigations and CAPAs.Oversee manufacturing activities to ensure...QualityFull time$70k - $105k
...industries. Our dedication to supplying quality products, on-time delivery, and... ...assists with quality planning, audits, root cause analysis, and corrective actions to ensure... ...IAW AS9100 & MIL-PRF-38534 Analyze and investigate the root cause of non-conforming product...QualityWork at office- ...Supervisory Criminal Investigator As a Supervisory Criminal Investigator, you will perform the following duties: # Serve as the... ...emotional and mental stability. Any physical condition that would cause the applicant to be a hazard to himself/herself, or others may...Work at officeLocal areaImmediate start
- ...strategic Inspection Manager to lead our quality team, safeguard our zero-defect culture,... ...(FAIs) and complex final inspections. Root Cause Analysis: Lead Material Review Board (... ...drive Corrective and Preventive Actions (CAPA). Equipment Mastery: Oversee the calibration...QualityPermanent employmentAll shifts
- A national investigative services firm is seeking a motivated Surveillance Investigator in Mastic Beach. The ideal candidate should have a strong work ethic, problem-solving skills, and the ability to manage time effectively. Responsibilities include conducting investigations...Flexible hoursWeekend workAfternoon shiftEarly shift
- ...Scope Reporting to the Senior Director of Quality is a multi-disciplinary management role... ...Management Ownership for Deviation, CAPA, Change Control, Documentum Control, Annual... ...products. Lead on-site QA activities in investigating deviations, CAPAs, or other compliance issues...QualityWeekend work
$70.2k - $85k
...Skills, and Abilities Familiarity with distributed computing, HPC environments, and cloud platforms. Experience building production‑quality software and ML pipelines. Familiarity with Git, CI/CD, containerization (Docker), and reproducible workflows. Experience...Quality- ...Quality Assurance ManagerJoin our team and play a critical role in driving product quality, food safety, and regulatory compliance across our manufacturing operations. In this leadership position, you will oversee the development and execution of quality systems, foster...Quality
$145k - $160k
...OOTs, failures, yield losses, contamination events; lead investigations, impact assessments, CAPAs, and batch disposition supportEstablish and improve... ...manufacturing environment. High attention to documentation quality, compliance, audit readiness, and patient safety....QualityLocal areaFlexible hours- Quality Engineer • Manage non-conformance reports (NCRs) and drive corrective actions (CAPA) • Lead MRB activities and coordinate with Engineering, Quality, and Manufacturing teams • Conduct Root Cause Analysis (8D, 5 Whys, Fishbone) • Reviewing and authorizing returned...Quality
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