Senior Quality Investigations Specialist - GMP/Pharma
Merck & Co.
Amneal is seeking a Senior NOI Investigations Specialist to perform independent investigations into aberrant events impacting product quality. You will conduct root cause analyses and write regulatory-ready reports, supporting timely ANDA submissions and product releases. Requirements include a BA/BS in science or engineering, 4+ years in pharma/medical device environments, and experience with GMP/FDA systems. A competitive benefits package is offered. #J-18808-Ljbffr Merck & Co.
- Amneal Pharmaceuticals seeks an NOI Investigations Senior Specialist to lead investigations into aberrant events affecting product quality and release. You will perform interviews, assess... ...science or engineering and 4+ years in GMP/FDA regulated environments, with strong...Senior
- Amneal is seeking an NOI Investigations Specialist to drive investigations into aberrant events affecting product quality. You will interview, gather facts, perform... .../engineering field, 3+ years in pharma/medical device, and hands-on GMP/FDA experience in production or lab...Suggested
- Amneal is seeking a Senior NOI Investigations Specialist to independently lead investigations into aberrant events impacting product quality, ensuring timely validations for ANDA submissions and... ...corrective actions, maintaining GMP compliance, and collaborating with management...Senior
- ...Pharmaceuticals LLC in New York is seeking an NOI Investigations Specialist to perform independent investigations... ...aberrant events affecting product quality and release decisions. You will... ...CAPA effectiveness reviews, and ensuring GMP compliance across activities,...Suggested
$105k - $115k
The Sr. Quality Management Systems Specialist provides coordination and reporting that includes data collection... ...Additionally, supports preliminary investigations and prepares a summary of the... ...expert for electronic QMS. Provides Senior Quality Management leadership with...SeniorFlexible hours- ...Town of Brookhaven, NY is seeking a Senior NOI Investigations Specialist to perform independent investigations... ...aberrant events affecting product quality and release. You will interview, analyze... ...regulatory scrutiny. Ensure GMP compliance and CAPA effectiveness while...Senior
$156k - $185k
Nature and ScopeThe Senior Manager of manufacturing will be responsible... ...data integrity for all GMP processes and any department-... ...development of people & team, quality expectations, compliance,... ...for “on-time” completion of investigations, CAPA’s for major and critical...SeniorFull timeTemporary workImmediate start$120k - $145k
...network systems. Working with Manufacturing, Quality, Validation, IT/OT, vendors, and... ...impact and risk assessments, deviations, investigations, CAPA, access reviews, audit-trail reviews... ...engineering experience in sterile or aseptic GMP pharmaceutical, biotechnology, or life-...SeniorFor contractorsWork at officeLocal areaFlexible hours- American Regent, Inc. is seeking a QA Senior Specialist - CAPA to ensure corrective and preventive actions and their effectiveness checks are... ...and supports SNCR processes, regulatory audits, and Quality Council activities. The successful candidate will drive CAPA...Senior
$80k - $95k
Nature and Scope The QA Senior Specialist - CAPA is responsible for ensuring that Corrective and... ...regulatory audit activities, and the Quality Council process. This is a cross-... ...maintain relationships with colleagues, investigators, CAPA owners and staff in facilitating...Senior- ...them, and participate in method transfer activities. You will document steps, review data for completeness and compliance, and assist investigations of abnormal results. A solid background in analytical chemistry and GMP knowledge is required. #J-18808-Ljbffr OperationsSenior
$110k - $125k
Description:The Senior Process Engineer in sterile manufacturing... ...improvement and facilitating investigations to resolve process deviations... ...performance indicators—including quality, yield, throughput, cycle... ...in engineering roles within a GMP manufacturing environment/Life...SeniorLocal areaFlexible hours- ...in method transfer activities within or between facilities. You will also help improve analytical procedures and comply with cGMP requirements, review data, and investigate anomalies. A mandatory OSHA-compliant respirator fit test is required. #J-18808-Ljbffr OperationsSenior
$110k - $125k
...Description: The Senior Facilities Engineer will lead construction, utilities, and equipment installation for the sterile facility... ...evaluate modifications across systems and procedures. Support investigations by identifying root causes, analyzing relevant data, and driving...SeniorFull timeContract workLocal area- ...in Upton, NY is seeking a Lead Assessor/Integrated Assessment Specialist to drive independent assessments across research and operations... ...requires a engineering-related degree and 3+ years in quality-management fields, with strong reporting, regulatory interpretation...For contractors
$93k - $123k
...execution, calculate and report results. Actively participate in investigation of laboratory results. Review laboratory analysis data for... ...analysis. Must understand and apply cGMP requirements applicable to quality control laboratory. Must have ability to apply advanced...SeniorFlexible hours- Nature and Scope Reporting to the Senior Director of Quality is a multi-disciplinary management role that will interact with all phases of production... ..., processes and products. Lead on-site QA activities in investigating deviations, CAPAs, or other compliance issues associated...SeniorWeekend work
- Spectra Tech, Inc. is seeking a Radiological Control Technician 2 in Upton, NY. The role requires a High School Diploma and three years of radiological protection experience. You will assist with the radiation protection program, calibrate safety measures, and analyze data...Senior
- American Regent, Inc. is seeking a high-level Quality leader reporting to the Senior Director of Quality, guiding the quality management system for sterile injectable manufacturing. You will oversee laboratory operations, regulatory inspections, supplier quality, and external...Senior
- ...Laboratory seeks an experienced Lead Assessor/Integrated Assessment Specialist to advance Independent Oversight and the Contractor Assurance... ..., execute independent assessments, and report findings to senior management, ensuring regulatory and contractual compliance across...SeniorFor contractors
- Spectra Tech has an immediate need for a Radiological Control Technician 2 in Upton, NY. Radiological Control Technician II, RCT II, ( Senior technician ) Primary Function: Performs HP assignments requiring technical skill and knowledge. Education and Experience High...SeniorImmediate start
- ...leading environmental consulting firm is seeking an experienced Environmental Project Manager/Scientist in New York to oversee site investigation and remediation projects. This full-time role requires 10+ years of environmental experience and strong project management...SeniorFull time
- Operations in the Town of Brookhaven is seeking a Sr. Quality Management Systems Specialist who will coordinate and report on various Quality Management processes. The role involves data collection, analysis, and regulatory compliance, contributing to quality assurance...Senior
- Taxpayer ServicesWHAT IS TAXPAYER SERVICES? A description of the business units can be found at are to be filled in following area(s):TS - RICS-Return Integrity and Compliance ServicesSenior
$275k - $285k
...pharmaceutical manufacturer in Shirley, NY. We are seeking a Sr. Director Quality Affairs to provide strategic leadership across site-wide... ...operations. skills: Good Manufacturing Practices (GMP), Quality Assurance (QA), Sterile Manufacturing, Regulatory Audit...SeniorPermanent employmentTemporary workWork experience placement$96.8k - $145.2k
...day at Zebra.What We're Looking For:The Senior Electrical Design Engineer will be responsible... ...this senior role is also to proactively investigate, learn, and implement Artificial... ...well as efficiency improvementPrioritizes quality and seeks out improvements in all aspects...SeniorFull timeSummer workWork at officeLocal areaFlexible hours3 days per week- ...At Your Service Staffing is seeking an experienced Accounting & Payroll Specialist to support payroll and invoicing across multiple companies and locations within our staffing organization. This is not an entry-level role — candidates must already have strong payroll...SeniorImmediate start
$113.05k - $180.9k
Electrical Engineering ProfessionalThe Modernization Project Office (MPO) is seeking an experienced electrical engineering professional with project management experience. The individual shall have a minimum of seven years of electrical engineering design with project ...SeniorContract workFor contractorsWork at office- Large Business & International Division What is Large Business & International (LB&I) Division? A description of the business units can be found at: Position(s) are to be filled in following area(s): ~ Director Treaty and Transfer Pricing Operations (TTPO...Senior
- ...Recruiter/Senior RecruiterOnsite/Hybrid RoleAs a U.S. Department of Energy national laboratory, Brookhaven operates within a uniquely... ...success managing multiple complex requisitions while maintaining quality, organization, and responsiveness.Proven ability to partner...SeniorFor contractorsWork at officeRemote workFlexible hoursNight shift
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