- Bristol Myers Squibb (Indianapolis, IN)
- …entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager , IT - GxP Computer Systems Validation & IT Process Lead is ... address process deficiencies. Work collaboratively with peers within various departments and Quality groups. + Provides validation subject matter expertise (SME)… more
- Novo Nordisk (Bloomington, IN)
- …+ Method Validation + Accountable for daily operations to maintain Quality standards and project timelines, including execution of method validation work, ... to embark on life-changing careers, and the opportunity to help improve the quality of life for millions of people around the world. Our Bloomington, Indiana… more
- Novo Nordisk (Bloomington, IN)
- …as oversight of the equipment calibration and preventive maintenance program and validation activities. Quality Assurance Operations group has oversight of the ... + 7 years GMP experience or other regulated industry + 5 years providing quality assurance support to cGMP pharmaceutical production or other regulated industry… more
- Catalent Pharma Solutions (Greendale, IN)
- ** Manager , Quality Systems** **Position Summary** Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is ... services to solve difficult development and manufacturing challenges. The ** Manager , Quality Systems** is responsible for the...FSMA PCQI lead for the site. + Responsible for validation of the Food Safety Preventative Controls. + Manage… more
- Stryker (Fort Wayne, IN)
- **Stryker** is hiring a ** Manager , Software Design Quality ** to manage a team of Design Quality engineers that work on Software as a Medical Device (SiMD) or ... projects, allocate resources, and make strategic decisions that enhance product quality . + Oversee product development, verification, validation , risk… more
- Novo Nordisk (Bloomington, IN)
- … Manager , QC Essential Functions + Independently executes and properly documents cGMP Quality Control testing + Independently operates basic and moderately ... release of bulk drug substance and drug product. Method Validation : Analytical testing, data analysis, document writing, and data...complex cGMP Quality Control equipment + Assists in… more
- Endo International (IN)
- …master document like standard operating procedures, batch packing, events, process validation , qualification documents and other quality documents. Supporting to ... document like standard operating procedures, batch manufacturing, incidents/events, process validation , annual product reviews, master datas, protocols and qualification… more
- Lilly (Indianapolis, IN)
- …and scale-up/optimization for Ph3 and commercial launches. **Responsibilities:** The Sr. Manager of TS/MS Sterility Assurance is responsible for leading/mentoring a ... scope of responsibilities includes aseptic process support, EMPQ, Sterilization Validation , Aseptic Process Simulations, and contamination control. Key deliverables… more
- Novo Nordisk (Bloomington, IN)
- …team + Collaborate significantly with cross functional groups including Validation , Quality Control, Manufacturing, Process Development, and Facilities ... systems + Collaborate significantly with cross functional groups including Validation , Quality Control, Process Engineering, Manufacturing, Process Development,… more
- Bristol Myers Squibb (Indianapolis, IN)
- …team, RayzeBio aims to be the global leader in radiopharmaceuticals. The Sr. Manager , IT Digital Plant Applications & Automation is an integral part of bringing ... maintenance of IT, lab & process automation systems (including MES, LIMS, local manufacturing, quality control and quality management site IT systems) as well as… more
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