March 2, 2018 – Validation Lead – p b Job Description: /b /p ul li Must have hands-on experience in Validation in GMP environment. /li li Experience in Life Science R&D space is
February 13, 2018 – Validation Lead – Job Description: Validation/SDLC lead provides guidance to business and project teams in Software Development Life Cycle (SDLC)/Computer System Validation (CSV)/Lab Systems/Lab Equipment/Infrastructure Qualification standards and practices.
February 9, 2018 – Regulatory Affairs Contractor – Responsibilities: Prepare and submit product, manufacturing, packaging, or labeling/IFU changes to European Notified Body, as required through Significant Change Supplements or Notifications. Prepare 510(k)’s to FDA pertaining to device changes requiring FDA clearance, as required and as determined by regulatory strategy. Submit notifications to Regulatory Affiliates pertaining to changes to product, manufacturing, packaging, labeling, etc.
February 9, 2018 – Manager, Biostatistician – Job description: Work with the clinical study team on study design, development and/or review of clinical study protocols. Contribute to clinical trial design, protocol concept sheet and protocol development.
Participate study related activities and provide statistical support such as reviewing Case Report Form (CRF) and guidance, validating randomization scheme and developing Study Quality Surveillance Plan (SQS), reviewing Independent Radiology Review Committee Charter and data transfer plan, etc.
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January 4, 2018 – QA Engineer – p b Job Description: /b /p ul li Experience authoring process and system validation and verification SOPs. /li li Experience on Internal
January 4, 2018 – SAS Programmer – p b Job Description: /b /p ul li Proven experience with SAS Office Analytics, SAS Visual Analytics, and SAS Financial Management software. /li