- Fujifilm (Holly Springs, NC)
- …milestones and deliverables. This role supports Good Manufacturing Practices ( GMP ) compliant laboratory operations in accordance with regulatory guidelines and ... to QC Sample Plans and DS/DP Specifications + Participates in updates of controlled GMP documents related to QC Sample Plans and QC Specifications + Participates in… more
- Merck (Elkhorn, NE)
- …and utility systems maintain their validated state and new systems meet GMP requirements. Additionally, the role may take on additional responsibilities to develop ... biotech, or related manufacturing industry + Awareness of Good Manufacturing Practices ( GMP ) in regard to documentation + Aseptic processing experience + Comfortable… more
- Merck (Rahway, NJ)
- …to maintain facility, utilities, and manufacturing equipment in accordance with GMP and Safety requirements, while applying Reliability Maintenance best practices to ... root causes and any related corrective actions/ preventive actions (CAPA). Maintain GMP documentation where applicable, such as GMP engineering drawings and… more
- Merck (Durham, NC)
- …and site services. + Ensure equipment calibration programs are GMP -compliant; maintain integrity of equipment identification and specifications within the ... schedules and execution across maintenance, calibration, capital project work, and GMP cleaning; chair/attend daily shutdown meetings to track completion. +… more
- Eurofins US Network (Groton, CT)
- …real-time dashboards & analytics. + Ability to work in a GLP or GMP environment with appropriate documentation and safety practices. + Responsible for utilizing ... analytical methodologies, systems, and processes to support GMP release and stability testing of clinical supplies for drug substance and drug product, throughout… more
- Aerotek (Chambersburg, PA)
- …packaging equipment, performing preventative maintenance, and ensuring compliance with GMP and HACCP/FDA regulations. **Responsibilities** + Operate filling and ... procedures and perform mechanical breakdowns. + Maintain compliance with all GMP and HACCP/FDA regulations, including daily production records and quality reports.… more
- Bristol Myers Squibb (Bothell, WA)
- …cleanroom manufacturing facilities, laboratories and outdoors at times and complies with GMP gowning and access requirements in these controlled areas. + Support the ... with urgency and agility. + Ability to comply with cleanroom and GMP manufacturing facility and laboratory gowning and entry requirements. + Experienced in… more
- Abbott (Abbott Park, IL)
- …role in the planning, execution, and delivery of construction projects for GMP manufacturing, office, warehouse, and lab facilities across all Abbott business units. ... outcomes. **Key Responsibilities:** * Develop and manage construction plans and schedules for GMP projects. * Plan and execute capital projects up to $20MM. *… more
- Kelly Services (Irvine, CA)
- …needed. + Coordinate and organize internal training program to ensure personnel performing GMP activities are trained per internal SOP. + Perform timely review of ... GMP records (Batch Records, Laboratory Records, Notebooks, etc). Work...and/or review SOPs, protocols, reports, change controls and other GMP documentation. + Conduct and/or review complaint, non-conformance, and… more
- Lilly (Lebanon, IN)
- …facility and the culture to enable a successful startup into GMP manufacturing operations._ **Position Description:** The Associate Director - Technical ... the necessary systems and business processes required to support GMP operations, and build the site culture. This will...resilience as the site grows to a full scale GMP manufacturing through start up. **Responsibilities** + Ensure technical… more
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