- PDS Tech Commercial, Inc. (Indianapolis, IN)
- …and business benefit of technical changes proposed. * Ensure creation of Master Batch Record . * Contribute to registration strategy and support registration ... analysis and conducting regular product specific data trending. * Review APQR and decide on state of control. *...Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws… more
- Bristol Myers Squibb (Indianapolis, IN)
- …documentation (eg, protocols, reports, validation activities, specifications, analytical methods, batch records , etc.) that support development, process ... manufacturing facility + Responsible for content development, compilation, maintenance, and review of the facility DMF and/or authoring the facility-based Quality… more
- Novo Nordisk (Bloomington, IN)
- …corrected vision + Abillity to pass color vision test + Ability to maintain batch records and/or laboratory notebook and complete all laboratory documentation in ... + Ability to add, subtract, multiply, divide and to record , balance, and check results for accuracy + Ability...and check results for accuracy + Ability to peer review data to ensure data is well organized with… more
- Cardinal Health (Indianapolis, IN)
- …hands-on execution of manufacturing procedures, following standard operating procedures (SOPs), master batch records (MBRs), and protocols. + Lead and/or support ... all production equipment, including clean rooms and isolators. + Record and maintain systems regarding cGMP compliance such as...other status protected by federal, state or local law._ _To read and review this privacy notice click_ here… more
- Lilly (Lebanon, IN)
- …relate to the activities of the TS/MS group. Reviews and approves manufacturing batch records and other manufacturing documentation. + Works with Process Team ... creating real-world solutions. The successful candidate should have a proven track record of driving technical and manufacturing agendas in small molecule. **Key… more
- Novo Nordisk (Bloomington, IN)
- …supporting CGMP programs, including the review and approval of project-specific batch records , procedures, protocols, and reports + Manages the oversight, ... review and approval of deviation investigations and change controls pertaining to CGMP production and testing + Supports the establishment, preparation, and… more
- Novo Nordisk (Bloomington, IN)
- …member + Ability to understand and write assigned SOPs and moderately complex batch production records with minimal guidance + Excellent written communications ... requirements. Relationships Supervisor Facilities & Maintenance Essential Functions + Review the HEPA certification schedule. Collaborate with operations and… more
- Novo Nordisk (Bloomington, IN)
- …solve to initiate and execute/monitor corrective action + Ability to write SOPs, batch production records and reports independently + Ability to work with ... well as programs for multiple pieces of manufacturing equipment + Ability to peer review data to ensure data is well organized with complete documentation + Ability… more
- Lilly (Lebanon, IN)
- …technical documents, including Change Controls, Regulatory Submissions, Deviations, Validations, Batch Production Records , SOPs, Process Flow Documents, etc. ... + Coordinate technical projects (experimental, modeling and/or production data analysis) to improve process control, yield, purity and/or productivity. + Prepare Annual Product Reviews. + Guide the development and implementation of new manufacturing… more
- Novo Nordisk (Bloomington, IN)
- …Manufacturing Auditing team oversees internal and external audits. The Analyst Team reviews batch production records , forms and logs. The third team is Process ... audit preparation, audit performance, documentation and metric tracking, documentation review , deviation identification and authoring, Corrective Actions, Change Management,… more