- 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 ... from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility… more
- Kelly Services (Plainfield, IN)
- …continuous improvement. **Key Responsibilities:** + Implement and enhance the QMS following regulatory requirements (ISO, FDA , EPA). + Manage audit programs and ... **Kelly Science & Clinical has a new, permanent opportunity for a Quality Manager in Plainfield, IN!** **Shift:** M-F | 8am-5pm **A Direct Hire Opportunity**… more
- Bristol Myers Squibb (Indianapolis, IN)
- …team at the RayzeBio Indianapolis manufacturing site. The position is a people manager position having supervisor responsibilities for up to 8 direct reports. The ... labeling, and warehouse operations including incoming material management. The Senior Manager , Operations Quality Assurance, RayzeBio is responsible for the cGMP/GDP… more
- Fujifilm (Indianapolis, IN)
- …Other + Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements ... **Position Overview** The Government Account Manager will be responsible for sales of the Fujifilm Healthcare Americas Corporation's (HCUS) full portfolio… more
- Rhythm Pharmaceuticals (Indianapolis, IN)
- …engagement with healthcare providers and patients and their families. Our commercial product is currently FDA -approved for two indications, and we have ... potential expanded product indication, you would transition to a Territory Manager (sales role), with responsibility for all approved indications. In Stage 1,… more
- Novo Nordisk (Bloomington, IN)
- …from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility ... and mentor engineers/senior engineers on execution. Relationships Reports to Manager , Validation. Essential Functions + Equipment Validation + Lead execution… more
- Novo Nordisk (Bloomington, IN)
- …from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized facility ... Nordisk and help us make what matters. Primary - Drug Product Primary Manufacturing produces sterile pharmaceuticals. The department includes equipment preparation,… more
- Cardinal Health (Indianapolis, IN)
- …testing of products or processes. + Has knowledge of testing methods, product usage, and applicable regulations and standards. + Established test methodology and ... analysis of raw materials, drug substance, in-process and drug product testing. + Is a quality lead for the...event is handled in accordance with site SOPs and regulatory requirements + Oversees chemists and contractors who operate… more
- Abbott (Westfield, IN)
- … requirements. + Complies with US Food and Drug Administration ( FDA ) regulations, other regulatory requirements, Company policies, operating procedures, ... processes. + Provides concurrent training to process trainees. Notifies the department manager of the need to replenish supplies/materials and of any difficulties… more
- Cardinal Health (Indianapolis, IN)
- …procedures, and processes to ensure products and services comply with regulatory standards and specifications. Quality Assurance develops and implements a compliant ... concepts and technical capabilities, the Senior Principal Specialist supports the Manager , Quality Assurance in overseeing the deviation process, CAPA and Risk… more
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