- Merck (Rahway, NJ)
- …including engineering studies, design verification protocols, stability studies and validation protocols, ensuring appropriate selection of acceptance criteria and ... following knowledge is a plus: + 21 CFR Part 4 + 21 CFR 211 + FDA Guidance for Industry, Container Closure Systems for Packaging Human Drugs & Biologics + ISO 13485… more
- Insight Global (Scotch Plains, NJ)
- …with benefits delivered as committed required. Experience in GxP systems, Computer System Validation , and consistent track record in the support of FDA regulated ... systems and business required. Vendor management experience preferred. Strong interpersonal skills required. Excellent communication, networking, and influencing skills including the ability to manage across all management and organizational levels required.… more
- Daiichi Sankyo Inc. (Basking Ridge, NJ)
- …Dx partner for CDx project contracts. Supports CDx analytical and clinical validation studies in collaboration with Dx-partner + Provides scientific and technical ... content and providing review of documents supporting CDx submissions to the FDA and other health authorities globally + For late-stage programs, executes the… more
- Merck (Rahway, NJ)
- …+ Experience authoring regulatory filings, and demonstrated working knowledge of FDA , ICH, and other regulatory requirements for CMC. Strong understanding of ... and deliverables (eg, equipment fabrication, FAT, SAT, qualification / validation ) Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld) Current Contingent Workers… more
- Sumitomo Pharma (Trenton, NJ)
- …programmers on SDTM/ADaM datasets and TLF specifications. + Perform programming validation for key derived datasets and oversee Quality Control (QC) efforts ... Statistics + Good understanding and working knowledge of GCPs, ICH guidelines, FDA and other applicable country regulations + Advanced proficiency in BASE SAS… more
- Cytel (Trenton, NJ)
- …of CRFs, edit check specifications, data transfer specifications, and data validation plans. + Performing statistical analyses and interpreting statistical results. ... and explain the methodology and consequences of decisions. + Understand and follow FDA regulations which affect the reporting of clinical trial data. This includes… more
- Cardinal Health (Trenton, NJ)
- …meetings as scheduled and follow up on improvement actions. + Support process validation and calibration programs and activities for the portfolio. + Manage and ... standards, principles, and techniques utilized within the Quality Assurance field + FDA regulated industry experience as well as applicable Quality System Standards… more
- Eurofins (North Brunswick Township, NJ)
- …tests on cosmetics and pharmaceuticals as recommended by current USP, FDA , and AAMI/ISO regulations. * Routine Quality Control of laboratory equipment, ... Limulus amoebocyte lysate (LAL) Sterility for Medical Devices, Off-Site Clean Room Validation and Monitoring, etc. + 3 year of experience with GMP/ISO/USP, etc.… more
- Zimmer Biomet (Farmingdale, NJ)
- …in department and cross functional meetings as necessary. + Executes validation protocols, gage repeatability and reproducibility (R&R) testing, data analysis and ... of duties. + Computer literate: Microsoft Word, Excel and Power Point. + Knowledge in FDA & ISO regulations are a plus. **Your Background** + High school diploma or… more
- Zimmer Biomet (Farmingdale, NJ)
- …charters, manage project implementation). + Support Engineering team in validation activities. + Support Site Engineering Change Requests (creation, management, ... duties in compliance with applicable regulations and standards such as FDA Quality System Regulation and ISO (International Organization for Standardization). +… more
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