- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …lot release and stability, ensuring conformance to approved procedures and cGMP + Review SOPs, logbooks, and other documentation related to daily QA activities ... provides Quality Assurance support across manufacturing operations, including batch record review , raw material release, and oversight of GMP activities. The… more
- Parexel (Trenton, NJ)
- …of critical data. Support close to real time clinical data Ongoing medical review with transparent documentation of the activity, related findings, and its ... important protocol deviations (iPD), providing input for compilation and review of trial iPD list from medical perspective, and...and timely milestones. + Medical input into Data Management documentation for the trial, such as eCRF design by… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …to ensure optimal conditions for production. + Accurately document data and review completed batch records to ensure products meet specifications. + Assist in ... the review and revision of SOPs and batch records as...supervision and report any irregularities. + Complete all required documentation in compliance with FDA regulations. + Support the… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …of master Preventive Maintenance/Calibration schedule. + Planning, execution and review of instrument calibration/qualification related activities as per the ... calibration master plan. + Draft and review of instrument operation, maintenance and calibration procedures. +...new and existing instrument and its procedures. + Concurrent documentation of all the raw data, observations in the… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …and loaded correctly in operational systems (document anomalies as appropriate). Review , process and validate all claims, administrative fees and rebates identifying ... and other payments. Develop SOPs and user guides, and expand/update existing documentation . Load contracts into revenue management system (SAP and Vistex) as… more
- GAP Solutions Inc (Trenton, NJ)
- …community relations by answering incoming calls and processing web tips. They will review , analyze, and process tips for further action. The HSITL operates around ... The Jr. Customer Service Representative (CSR) will provide intake, analysis, and documentation support to the Homeland Security Investigations (HSI) Tip Line, a… more
- GAP Solutions Inc (Trenton, NJ)
- …community relations by answering incoming calls and processing web tips. They will review , analyze, and process tips for further action. The HSITL operates around ... Customer Service Representative (CSR) will provide senior-level intake, analysis, and documentation support to the Homeland Security Investigations (HSI) Tip Line, a… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …is compliant, effective, and aligned with corporate and regulatory standards. + Review **Device History Records (DHRs)** and ensure documentation accuracy. + ... Manage and maintain documentation within **TrackWise** and other electronic systems. + Review and update **SOPs** to ensure alignment with FDA, ISO, EU MDR, and… more
- Parexel (Trenton, NJ)
- …provide regulatory guidance in collaboration with global regulatory leads Submission & Documentation Excellence - Prepare, coordinate, and review CMC and ... is a plus - Ensure audit readiness and version control through meticulous documentation and system management Qualifications Experience & Expertise - 4-6 years of… more
- Parexel (Trenton, NJ)
- …maintaining internal ROI reporting of team efforts, and supporting internal and external review / approval clinical & MLR process and related documentation ... Standard Operating Procedures + Assist with the development and review of content and participate in UAT (User Acceptance...as needed + May contribute to the development and/or review of content for presentations and operations plans for… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …Vistex agreement management platform 1. **Open Claims/Chargeback Team Lead:** _Manage end-end review and co-ordination of open claims and receivables by customer_ + ... customer deductions and credits for reconciliation. + Provide any supporting documentation as required (by customer), in collaboration with Sales directors, to… more
- Parexel (Trenton, NJ)
- …applications in eCTD format - Respond to Health Authority questions during IND/NDA review phases - Review and approve technical documents across Clinical, ... frameworks - Experience with international clinical trials and regulatory documentation - Strong communication, leadership, and collaboration skills -… more
- Parexel (Trenton, NJ)
- …+ Collectively and periodically (eg quarterly) perform a Therapeutic Area (TA) level review of quality plans and risk mitigation approaches in order to identify any ... to: + Facilitating and monitoring CTT oversight of vendors + Development, review and revision of quality agreements with business partners (ie co-development of… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …evaluates proposed changes to compendial or in-house methods. Prepare and review the technical and compliance documents such as analytical methods, specifications, ... and FDA /ICH guidelines, CAPAs, Lab Event/Out-of-Specification and Out-of-Trend investigations. To review the USP and other compendia changes on a timely basis and… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …equipment + Implement improvements to procedures, and revises SOPs and GMP documentation as required + Interact with internal and external auditors including ... in a state of cGMP compliance + Perform and review growth promotion testing data for qualification of microbial...reports related to departmental activities and product testing + Review Microbiology testing data as required + Coordinate receipt… more
- Dr. Reddy's Laboratories (Princeton, NJ)
- …and report into the Finance Controlling Team. **Responsibilities:** - Receive, review , and verify invoices for accuracy, completeness, and proper authorization. - ... timely payments release. - Maintain organized records of invoices and related documentation . - Assist with month-end and year-end closing activities. - Ensure… more
- Red River (Trenton, NJ)
- …on how to effectively utilize Microsoft 365 applications and features. Create documentation , user guides, and knowledge base articles to assistcustomers in adopting ... excellent benefits and an exceptional work environment. You can review our benefit (http://redriver.com/wp-content/uploads/2024/12/2025-Red-River-Technology-BAAG\_12.19.24-1.pdf) offerings here. If you are… more
- Sun Pharmaceuticals, Inc (Princeton, NJ)
- …. + Ensure laboratory compliance with **cGMP standards** through internal inspections and documentation review . + Mentor and train junior analysts in lab ... techniques, instrumentation, and processes. + Perform monthly maintenance and cleaning of lab equipment and instruments. + Support visual inspection qualification and other assigned duties. **Job Qualifications and Experience:** + **Bachelors degree** in Life… more
- Integra LifeSciences (Princeton, NJ)
- …assessments of existing products for consideration in new product development. + Review for approval Risk Management Documentation including but not limited ... to Risk Management Plan/Report, Hazard Analysis, Benefit-Risk Analysis, dFMEA, pFMEA, aFMEA. + Participate in design and change control activities. + Participate in FDA inspections, ISO Certification and Surveillance audits and Internal audits. + Collaborate… more
- MISTRAS Group, Inc. (Princeton Junction, NJ)
- …the responses and information provided in this application (including any other supporting documentation such as a cover letter, resume, or transcript) are true and ... rights pursuant to federal employment laws. For further information, please review the Know Your Rights (https://www.eeoc.gov/poster) notice from the Department of… more
