- Kestra Medical Technologies, Inc (Kirkland, WA)
- …experience. * 3+ years' directly relevant experience, with prior experience in an FDA /cGMP or regulated environment. * Working knowledge of PPAP and IQ/OQ/PQ ... validation techniques. * Strong written and verbal communication skills....or sitting for prolonged periods of time * Frequent computer use * Frequent phone and other business machine… more
- Hologic (Newark, DE)
- …of our mission to improve lives worldwide. **Knowledge:** + Working knowledge of FDA Quality System Regulations (21 CFR 820), ISO 13485, and Medical Device Directive ... and regulatory requirements for medical devices. **Skills:** + Strong computer skills, including proficiency in word processing, spreadsheets, and databases.… more
- BD (Becton, Dickinson and Company) (Columbus, NE)
- …equipment design meets safety and operational standards based on experience and validation from respective stakeholders. + Leads suppliers and external design teams ... ISO standards and Lean Manufacturing concepts desired. + Experience in an FDA regulated quality environment desired. + Willingness and ability to travel domestically… more
- BD (Becton, Dickinson and Company) (Sparks, MD)
- …requirements and sound understanding of the pertinent Quality System/Regulations. + Computer skills in word processing, spreadsheets and a statistical package ... + Moderate knowledge and understanding of the Food and Drug Administration ( FDA ) 21 CFR 820 and International Organization for Standardization (ISO) ISO 9000:2000… more
- Nestle (Franklin Park, IL)
- …packaging material changes (New implementation). + Write protocols and assist with validation activities across the business unit. + Assist in internal audits and ... support external certifications ( FDA , Kosher, FSSC, Organic). + Develop and deliver Quality...dietary supplements industry + Knowledge of continuous improvement + Computer skills to include proficiency with Microsoft Office Suites… more
- Hovione (East Windsor, NJ)
- …equipment and utility systems according to regulatory demands (cGMPs, FDA requirements, etc.), industry applicable guidelines and internal procedures. Contributes ... health authorities, in the scope of the Qualification and Validation area - Lead functional teams or projects by...audits - Fluency in written and verbal English - Computer literate with good working knowledge of the MS… more
- Endo International (St. Louis, MO)
- …people. + Understanding of basic statistical principles, expert knowledge of validation principles, techniques, and regulatory expectations. + Knowledge of US and ... direct reports. Develops strategic objectives for groups managed. Contact with FDA as subject matter expert during site inspections. Regular contacts including… more
- Sumitomo Pharma (Providence, RI)
- …+ Assist in signal detection activities including data assembly, signal validation , and signal evaluation. + Perform literature monitoring (with vendor support) ... oncology, and/or neurology is strongly preferred. + Comprehensive understanding of FDA and EU legislation and GCP/GVP/ICH safety guidelines for investigational and… more
- Integra LifeSciences (Braintree, MA)
- …issues. + Ensure compliance with safety, environmental, and regulatory standards (eg, FDA , ISO). + Maintain accurate records of refrigerant usage and system ... environmental conditions (cold rooms, mechanical spaces, etc.). + Basic computer skills and experience with CMMS (Computerized Maintenance Management Systems).… more
- Abbott (Liberty, SC)
- …Compile and organize data to support the generation of engineering test and validation reports. Collect and analyze process yield data. + Inspect and disposition ... requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, processes,… more