- Lilly (Lebanon, IN)
- …GMP manufacturing through start up. **Responsibilities:** + Maintain compliance with all regulatory requirements at all times. + Support the execution of the ... conditions and they are maintained in accordance with local and corporate regulatory requirements. + Enter Trackwise events, participate in and lead CAPA… more
- Novo Nordisk (Bloomington, IN)
- …model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized ... assigned pertaining to single technology lanes + Assist in responding to customer/ regulatory audit observations and corrective actions + Review and approve changes… more
- Lilly (Indianapolis, IN)
- …technical documents including annual product reviews, change controls, regulatory submissions, deviations, validations, and procedures. Monitor process control ... teams. Serve as interface with upstream suppliers and global device and drug product networks. #LI-DNI Position requires a Master's degree in Pharmacy,… more
- CSL Plasma (Indianapolis, IN)
- …primary center physician registered as the Laboratory Director with the Food and Drug Administration ( FDA ). **Job Description** + Serves as the primary physician ... for reporting to the Food and Drug Administration and in such capacity provides medical oversight...for completion of training and recommendation for certification by Regulatory Affairs. Functionally directs the Center Medical Staff. Provides… more
- Veterans Affairs, Veterans Health Administration (IN)
- …with all regulatory and accrediting body requirements (eg, TJC, DEA, FDA , etc.) k. Analyzes and allocates available resources and identifies risk areas which ... in a testing designated position are subject to urinalysis to screen for illegal drug use prior to appointment. Applicants who refuse to be tested will be denied… more
- Bristol Myers Squibb (Indianapolis, IN)
- …shipping of domestic and international shipments of internally manufactured radiopharmaceutical drug product programs. + Assist with the scheduling of domestic and ... the efforts to commercialize the distribution of current clinical programs upon FDA approval. + Execute the day-to-day warehouse operations as assigned by the… more
- Novo Nordisk (Bloomington, IN)
- …model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized ... with company SOP's, specifications, as well as cGMP, ICH, FDA , EMA regulations or guidelines + Able to lead...+ Begin to provide reliable and defendable interpretations of regulatory guidance for the customer + Well organized with… more
- Novo Nordisk (Bloomington, IN)
- …model from process and formulation to clinical and commercial biomanufacturing and drug product fill/finish and packaging. The Bloomington campus is a recognized ... guidelines + Recommend facility improvements to meet OSHA safety, ISPE, or FDA guidelines and improve efficiency + Create maintenance procedures and update existing… more
- Fujifilm (Indianapolis, IN)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... all other applicable laws, regulations, and standards. **Qualifications** To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge skill,… more
- Fujifilm (Indianapolis, IN)
- …+ Comply with all applicable US Food and Drug Administration (US FDA ) medical device regulatory requirements, applicable ISO 13485 standard requirements and ... all other applicable laws, regulations, and standards. + Comply with and pass all requirements for vendor credentialing as part of gaining access to hospitals and facilities to perform assigned job duties. **Qualifications** + BA/BS required. Biological… more