- Lilly (Indianapolis, IN)
- …compliance with quality systems and current Good Manufacturing Practices ( cGMP ). This oversight includes supporting drug substance manufacturing, central utilities, ... minimum of 3 years previous FUME engineering experience supporting cGMP manufacturing (QA, TSMS, operations, engineering, auditing, etc.). **Additional… more
- Lilly (Lebanon, IN)
- …in STEM Discipline (Chemistry preferred) and at least 3 years of experience in cGMP manufacturing, or master's degree and 1 year experience in cGMP ... Quality Control, Quality Assurance, or Development. + Familiarity with cGMP manufacturing environment and terminology. + Excellent analytical, interpersonal, written… more
- System One (Indianapolis, IN)
- …and thorough review of QC microbiology data for completeness, accuracy, and cGMP compliance * Verify raw data, calculations, instrument outputs, electronic records ... , Biology or Biotechnology or equivalent * Preferred training in Quality systems, cGMP , and Data Integrity Benefits System One offers eligible employees health and… more
- Bristol Myers Squibb (Indianapolis, IN)
- …execution, manages a cross-functional team, and ensures alignment with regulatory requirements ( cGMP , FDA, USP, and other relevant bodies). The ideal candidate has ... Qualifications** + Strong knowledge of pharmaceutical validation practices, including cGMP and FDA/USP/OSHA regulatory requirements. + Expert understanding of… more
- Controlled Contamination Services LLC (Indianapolis, IN)
- …and correctly. + Responsible for participating in continuous training: cGMP training, technical skills, safety, performance improvement. + Normal responsibilities ... follow through on corrective and preventative actions (variances). + Review change to cGMP documentation and re-train. + Assist in the cross training of other… more
- Lilly (Indianapolis, IN)
- …transfer for Bulk DS into clinical manufacturing + Input and authoring for cGMP and PRD Quality System compliant manufacturing master production records and review ... to influence and drive change **Additional Preferences:** + Understanding of cGMP requirements and regulatory compliance for clinical manufacturing + Experience with… more
- Lilly (Lebanon, IN)
- …or formal discussion (shift meetings, safety representative). + Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and ... with PSM-regulated/hazardous chemicals. + Solid understanding of FDA guidelines and cGMP requirements. + Strong organizational skills and ability to handle and… more
- Lilly (Indianapolis, IN)
- …Compliance:** Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals. Support ... team development. **Additional Preferences and Information:** + Knowledge of cGMP requirements in medical device manufacturing, highly preferred. + Experience… more
- Lilly (Indianapolis, IN)
- …Compliance: Ensure adherence to current regulatory requirements, including cGMP standards, OSHA regulations, and environmental sustainability goals. Support ... + Experience in device assembly and/or packaging. + Knowledge of cGMP requirements in medical device manufacturing. + Understanding of basic requirements… more
- Lilly (Lebanon, IN)
- …audits, procedure coordination, housekeeping and improvement projects. + Know and follow cGMP practices, safe work habits, plant dress code, hygiene standards, and ... with PSM-regulated/hazardous chemicals. + Solid understanding of FDA guidelines and cGMP requirements. + Strong organizational skills and ability to handle and… more