- Novo Nordisk (Bloomington, IN)
- …products and stability samples, while adhering to SOPs and working in a cGMP compliant environment. The position will analyze and interpret results in written and ... Manager, QC Essential Functions + Independently executes and properly documents cGMP Quality Control testing + Independently operates basic and moderately complex… more
- Novo Nordisk (Bloomington, IN)
- …contact for key customers + Manages QA resources assigned to supporting CGMP programs, including the review and approval of project-specific batch records, ... and approval of deviation investigations and change controls pertaining to CGMP production and testing + Supports the establishment, preparation, and communication… more
- Lilly (Indianapolis, IN)
- …process improvement of existing manufacturing methods via Current Good Manufacturing Practices ( cGMP ). + Produce radioisotopes and drug products following cGMP ... + Maintain accurate and complete lab data notebooks as per cGLP and/or cGMP , as appropriate. + Adhere to all applicable procedures, cGLP, cGMPs, company policies… more
- Lilly (Indianapolis, IN)
- …improvement of existing manufacturing methods via Current Good Manufacturing Practices ( cGMP ). **Roles and Responsibilities of the Position:** + Produce drug ... products following cGMP guidelines and resolve all production-related quality events in...radioisotopes in strict compliance with batch records, SOPs, and cGMP standards + Operate, monitor, and maintain production equipment… 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)
- …preferred) . 2+ years of proven experience in a training role ( cGMP experience preferred) . Demonstrated working knowledge of quality management systems and ... management software (LMS) . Demonstrated working knowledge of working in a cGMP facility (preferred) . Demonstrated experience in managing a training program for… more
- Lilly (Indianapolis, IN)
- …serve as a Site / Plant agent to manage compliance to all cGMP procedures, policies, and guidelines; support issue resolution, and approve recommendations related to ... reliable supply of quality medicine, strong quality culture, and maintenance of cGMP compliance and inspection readiness + Participate actively on the plant lead… more
- Lilly (Lebanon, IN)
- …comply with safety rules and closely following approved procedures to ensure cGMP compliance. + Document all work by following Good Documentation Practices. + ... compliance with safety rules and closely following approved procedures for ensuring cGMP compliance. **Basic Qualifications:** + 480 Volt switch gear + High school… more
- Kedplasma (Indianapolis, IN)
- …reactions. Operates within the scope Good Manufacturing Practice and FDA cGMP 21CFR. **JOB SUMMARY** Responsible for performing donor medical qualifications, ... of EU Guidance on Good Manufacturing Practices and FDA cGMP 21CFR. **ESSENTIAL JOB FUNCTIONS** Every effort has been...in accordance with SOPs, the FDA, OSHA, CLIA and cGMP and company policies as well as educational experience.… more
- Lilly (Lebanon, IN)
- …in STEM Discipline (chemistry preferred) and at least 5 years of experience in cGMP manufacturing OR Master's Degree and 3 years experience in cGMP ... in small molecule, peptide, or oligonucleotide API Manufacturing in a cGMP manufacturing environment. + Proven ability to work within cross-functional Process… more