- Aerotek (Carmel, IN)
- …involves preventive maintenance, acute maintenance, adjustments, and participation in validation and replacements. Candidates will oversee various areas including ... ensuring continuous learning and development. Enjoy working in a clean FDA -regulated facility with promotional opportunities available. **Work Environment** The role… more
- Cardinal Health (Indianapolis, IN)
- …of quality, analytical metrics and / or statistics, trending, quality planning, validation , CAPA and problem solving. + Works cross-functionally and has the ability ... functional units to achieve positive outcomes. + Assists Quality Management with FDA and other regulatory agency activities. + Demonstrates efforts to discovering,… more
- Lilly (Indianapolis, IN)
- …within the organization. **Compliance & Documentation** : + Ensure compliance with FDA and any other global applicable regulatory standards by keeping inspection ... documents (Global Q standards, Common Q practices, ) and execution documents ( validation reports, PoDs ) to support the visual inspection Quality System.… more
- Cook Medical (Spencer, IN)
- …production controls. (eg qualification, process capability, sampling plans, validation , etc.)- Perform investigation of product non-conformance/complaints, root ... May interface with internal or 3rd party audits. (eg FDA , Notified Body, etc.)- Drive continuous improvement efforts through...the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable… more
- Cook Medical (Bloomington, IN)
- …production controls. (eg qualification, process capability, sampling plans, validation , etc.)- Perform investigation of product non-conformance/complaints, root ... May interface with internal or 3rd party audits. (eg FDA , Notified Body, etc.)- Drive continuous improvement efforts through...the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, and other applicable… more
- Novo Nordisk (Bloomington, IN)
- …Controls The QA Representative's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems ... + Facilitate and maintain the site change control process in compliance with FDA , EU GMP, and other regulatory guidelines. + Manage change control records within… more
- Bristol Myers Squibb (Indianapolis, IN)
- …project delivery-including design, procurement, installation, commissioning, cost forecasting and validation of facility and various process technologies. As a ... hazardous equipment. * Establish a team of engineers in support construction, validation and ultimately the transition to daily site Engineering operations. * Mentor… more
- Bristol Myers Squibb (Indianapolis, IN)
- …radiopharmaceutical manufacturing site and process technologies, from design through validation and production launch. * Track facility construction activities, ... from construction to operational readiness, including facility qualification, equipment validation , and staff training. * Implement project management tools and… more
- Novo Nordisk (Bloomington, IN)
- …matters. The Position This role's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality systems ... + Drafts technical plans, protocols, control strategies, and reports related to process validation and process monitoring (eg, PPQ, CPV, APR / PQR) + Maintains… more
- Bristol Myers Squibb (Indianapolis, IN)
- …in Indianapolis. This role will conduct method development and method validation along with day-to-day activities to support commercialization of aseptically ... Support and perform testing for microbial test method development, qualification and validation for bioburden, sterility, and endotoxin testing + Support review and… more