- Novo Nordisk (Bloomington, IN)
- …quality assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality ... systems requirements. This includes systems implementation and...of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations group has oversight of… more
- Novo Nordisk (Bloomington, IN)
- …quality assurance functions. The department's primary function is to ensure compliance with FDA and other regulatory agency requirements as well as internal quality ... systems requirements. This includes systems implementation and...of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations group has oversight of… more
- Lilly (Indianapolis, IN)
- …experience supporting GMP environment including but not limited to analytical instrument computer system validation . + Ability to influence diverse ... Lab Informatics, Quality Assurance, and Information Digital Services. + Complete computer system installation and verification including Windows and application… more
- Lilly (Indianapolis, IN)
- …key business partners to deliver standardized data collection methods and innovative validation solutions for use in global clinical trials. Portfolio Delivery + ... design specifications and enable successful implementation + Program and test data collection systems and associated data repository mappings for a trial or set of… more
- Cardinal Health (Indianapolis, IN)
- …objectives. + Create, develop and maintain an effective Quality Management System that aligns with corporate procedures, client requirements and all applicable ... meetings as scheduled and follow up on improvement actions. + Support process validation and calibration programs and activities for the portfolio. + Manage and… more
- Cook Medical (Bloomington, IN)
- …within specific timelines and meeting performance expectations. + Adhere to the Quality Management System and its processes to meet FDA 21 CFR 820, ISO 13485, ... process and test method development (design for manufacturing/assembly, process validation , process capability, lean manufacturing, equipment selection and qualification,… more
- Novo Nordisk (Bloomington, IN)
- …through leading cross function teams to address process improvement, system improvement, new regulations/expectations, new business needs, training improvements, and ... verification + Accountable for completion of qPCR/PCR method development, qualification, validation , and execution + Accountable for daily operations of the site's… more
- Novo Nordisk (Bloomington, IN)
- …and safety requirements + Ability to use Excel, Word, and other office systems + Understanding of cGMP regulations, FDA guidelines, and industry standards ... Inspection & Packaging working cross-functionally with support groups including Validation , Quality Assurance, Engineering, and Manufacturing Science & Technology +… more