- Lilly (Indianapolis, IN)
- …for people around the world. **Organization Overview & Responsibilities:** The Analytical Quality & Integrated Services team within the Global Quality Analytical ... (CSV) Specialist to be responsible for qualifying and managing instrument software updates, handling change controls, writing CSV documents, and performing… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …through nextGen portals is a plus. + Interact with manufacturing and quality groups, partner organizations, regarding CMC issues. + Independently manage preparation ... local and/or global functional units [OPCJ CMC RA, Factory, Quality , MPDD, OPDC/OPEL Tech Ops] as well as affiliates,...investigational and marketed product submissions (IND, NDA, DMF) for FDA and equivalent submissions for Europe and Canda +… more
- Lilly (Indianapolis, IN)
- …Knowledge of Software as a Service (SaaS) cloud computing including quality and security requirements. + Must be familiar with file transfer protocols, formats, ... business teams, serialization trading partners, other supporting IT teams, and software suppliers in the global packaging space. Key deliverables and goals… more
- Novo Nordisk (Bloomington, IN)
- …use Excel, Word, and other office systems + Ability to learn and use quality management software such as TrackWise(R) or ComplianceWire(R) + Ability to ... life-changing careers, and the opportunity to help improve the quality of life for millions of people around the...and/or Engineers + Strong understanding of guidance documents from FDA , EMA, PDA, ISPE, ASME, ISO, and other industry… more
- Kelly Services (Bloomington, IN)
- …Standard Operating Procedures utilizing equipment/system/instrument or calibration software operating manuals, instrument specifications, etc. This candidate ... Implement feedback from technical teams to improve document integrity and quality . Ensure documentation complies with industry standards and regulatory requirements,… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …and guidelines. - Confirms submission documents are accurate, compliant, and high- quality to allow for smooth and expeditious approvals from regulatory authorities. ... with GRA department to execute departmental initiatives to improve overall efficiency, quality , and/or output. - Assess and develop innovative ideas to move GRA… more
- Chewy (Clayton, IN)
- …Responsible for partnering with the Site Operations team, Inventory Control, Learning, Quality , and Facility teams to manage the network food safety programs. ... safety initiatives, policies, and procedures + Work closely with Quality and Supply Chain to mitigate negative customer feedback...manufacturing setting + Must be a Qualified Individual by FDA definition and have comprehensive experience of FDA… more
- Otsuka America Pharmaceutical Inc. (Indianapolis, IN)
- …for consistent messaging. + Serves as the primary contact/liaison with the FDA Office of Prescription Drug Promotion (OPDP), responsible for establishing working ... procedures, as appropriate. + Recommends improvements to labeling policies, processes, quality , and system tools. Manages contracts for contractors and consultants.… more
- Fujifilm (Indianapolis, IN)
- …levels. + Minimum five (5) years of progressive experience as a Technical, Systems, Software or Quality Assurance Engineer in Medical IT and/or Imaging products. ... review calls with assigned staff for the purposeof evaluating and reporting project quality and timeliness. + Manages assigned projects as required to meet company… more
- Novo Nordisk (Bloomington, IN)
- …Excel, Word, and other office systems + Prior work experience with quality , operations and/or scientific management software such as TrackWise(R), ... experience + Proficient in Excel/Word/Teams and other data entry software + Leads a team and coordinates work tasks...work tasks assigned + Executes complex assignments with high quality + Knowledge of cGMP, ICH, FDA ,… more