- Kelly Services (Mooresville, IN)
- …handle, or feel; and reach with hands and arms. + Experience working in an FDA regulated environment is preferred, GXP and GMP experience is a plus **Apply ... assigned by Supervisor or Manager. + Responsible to comply with FDA standards ensuring applicable + Work Instruction accurately reflect daily activities… more
- Lilly (Indianapolis, IN)
- …pharmaceutical manufacturing processes and compliance with industry-specific regulations, such as FDA guidelines for Good Manufacturing Practices ( GMP ). + ... Certification in relevant IT areas (eg, ITIL, AI, Cloud, etc.) is a plus. **Other Information:** + Role is Monday through Friday and based on-site. Must be flexible in providing support to accommodate other inputs (production schedules, shutdowns, etc.).… more
- BioLife Plasma Services (IN)
- …**PREFERRED QUALIFICATIONS:** + Associates or Bachelor's Degree + Experience working with SOPs, GDP, GMP , CLIA, and the FDA + Experience working in a highly ... regulated or high-volume retail environment + Excellent interpersonal, organizational, technical, and leadership skills **About BioLife Plasma Services** Every day at BioLife, we feel good knowing that what we do helps improve the lives of patients with rare… more
- BioLife Plasma Services (Indianapolis, IN)
- …tasks require prolonged glove wear **PREFERRED QUALIFICATIONS:** + Experience working with SOPs, GDP, GMP , CLIA, and the FDA + Experience working in a highly ... regulated environment **We Offer Comprehensive Benefits from Day One** + Major medical, dental, and vision insurance and prescription coverage for eligible employees + A minimum of 15 vacation days and 10 company paid holidays + Tuition reimbursement +… more
- Bristol Myers Squibb (Indianapolis, IN)
- …. Develop, revise, and maintain technical documents for process equipment and GMP risk assessments. . Interpret P&IDs, equipment/system layouts, wiring diagrams and ... and executing plant maintenance and calibration activities in a GMP manufacturing facility. . Or AAS in Engineering discipline...company policies and any other quality or regulatory requirements. ( FDA , USP, OSHA, etc.) . Proficiency with MS Office… more
- Cardinal Health (Indianapolis, IN)
- …for raw material, work in process, and finished products. + Champion Quality, GMP compliance and EHS/Radiation Safety practices. + Develop and lead GMP /GDP ... in the release of the final product in compliance with applicable regulations ( FDA , EU, etc.) and marketing authorizations. + Responsible for the review and… more
- Catalent Pharma Solutions (Greendale, IN)
- …Engineer, Manufacturing Sciences and Technology (MS&T) is responsible for supporting GMP manufacturing operations as a project leader to commercialize new products ... of every patient, consumer and Catalent employee. **The Role** + Collaborate with GMP manufacturing and Product Development project teams as the MS&T project lead… more
- Novo Nordisk (Bloomington, IN)
- …Schedules employees and manages workload for operational area + Reviews and approves GMP documentation while ensuring safety and GMP quality compliance + ... 1-2 years relevant experience required + Leadership experience preferred GMP experience preferred GMP experience preferred +...with company SOP's, specifications, as well as cGMP, ICH, FDA , EMA regulations or guidelines + Able to lead… more
- Novo Nordisk (Bloomington, IN)
- …improvements + Ownership of Corrective Actions, Change Management, Audit Support as SME, GMP and document revision, review and approval + Lead and participate in ... understand decimals) + Required to read, understand, and follow GMP documents + Has basic knowledge of the principles...complex with high quality + Knowledge of cGMP, ICH, FDA , EMA regulations or guidelines + Intermediate understanding of… more
- Lilly (Lebanon, IN)
- …build the processes and facility to enable a successful startup into GMP manufacturing operations. **Position Brand Description:** The Utility Operator is directly ... and implement the necessary systems and business processes required to support GMP operations, and build the site culture. This will require significant… more