- Novo Nordisk (Bloomington, IN)
- …in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include manual, semi-automated and automated inspection, ... in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank… more
- Bristol Myers Squibb (Indianapolis, IN)
- …with RayzeBio policies, standards, procedures and global current Good Manufacturing Practice ( cGMP ). The Senior Manager provides Quality support and oversight ... RayzeBio aims to be the global leader in radiopharmaceuticals. **Summary** The Senior Manager , QA for QC is responsible for quality oversight of the Quality Control… more
- Novo Nordisk (Bloomington, IN)
- …in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include manual, semi-automated and automated inspection, ... in accordance with regulatory, site, and client requirements. Manufacturing cGMP production activities include solution preparation, master/working cell bank… more
- Bristol Myers Squibb (Indianapolis, IN)
- …for a Scientist I for the QC Microbiology department. Reporting to the Manager of Microbiology, this individual will help support the microbial contamination control ... local, state and federal/ISO policies and regulations + Participate in internal audits and audits conducted by external agencies and Regulatory Authorities… more
- Novo Nordisk (Bloomington, IN)
- …Team Novo Nordisk and help us make what matters. Relationships Reports to Manager . Essential Functions + Supplier Management + Provides support for the introduction ... controlled documents + Quality and Compliance + + Participates in internal audits , including coordinating the audit with relevant department subject matter experts,… more
- Biomat USA, Inc. (Merrillville, IN)
- …Performs documentation review for unsuitable test results. * Assists the Quality Systems Manager to ensure that cGMP regulation, SOPs and regulatory requirements ... Associate** **Summary:** Under the direct supervision of the Quality Systems Manager , perform quality assurance and Training functions to ensure compliance with… more
- Kedplasma (Indianapolis, IN)
- …Responsible for registering and screening donors under the direction of the Center Manager . Operates within the scope of EU Guidance on Good Manufacturing Practice ... and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been...issues or concerns. + Assists plasma collection center for audits . + Follows all SOPs and regulatory policies and… more
- Kedplasma (Indianapolis, IN)
- …of the donor during the plasmapheresis process under the direction of Center Manager . Operates within the scope of EU Guidance on Good Manufacturing Practice and ... FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been...to the donor. + Prepares plasma collection center for audits by maintaining a clean, efficient work environment times… more
- Lilly (Indianapolis, IN)
- …secondary standards. Position may be responsible for maintaining laboratories in a cGMP 21 CFR compliant state using validated equipment with trained personnel and ... and accurate standards use. + Convey needed resources to the Engineering manager . + Use appropriate methods, both temporary (hand changes) and permanent (change… more
- Novo Nordisk (Bloomington, IN)
- …improvements and equipment upgrades. + Ensure all automation activities comply with FDA, cGMP , and GAMP standards. + Participate in audits , investigations, and ... emphasis on DeltaV, PLC, and HMI technologies. Relationships Reports to Senior Manager , Process Engineering Schedule: regular business hours You will work closely… more