- Abbott (Abbott Park, IL)
- …manufacturing information systems (SAP) while performing manufacturing process steps. Applies GMP ; Bioburden reduction; and safety procedures. + After completion of ... material using required Personal Protective Equipment(PPE). + Performs routine maintenance and GMP activities while complying with GMP / ISO requirements. +… more
- Amgen (Holly Springs, NC)
- …Ensure commissioning and qualification of systems is completed in alignment with GMP requirements and interact with regulatory inspectors. + System guidance to ... unit operations + Direct knowledge of design and troubleshooting with GMP Biopharmaceutical Production facility equipment/systems such as cell culture reactors,… more
- SBM Management (Tustin, CA)
- …will be responsible for coordinating and managing project tasks in the GMP Program to ensure project delivery within allotted budget and timelines. Responsibilities: ... each essential duty satisfactorily. Other duties may be assigned. + Assist GMP managers and supervisors in day-to-day coordination, scheduling and management of… more
- Catalent Pharma Solutions (Harmans, MD)
- …Catalent's Baltimore and Harmans, Maryland sites provide industry-leading GMP development and manufacturing services for advanced biopharmaceuticals, including ... from downtown Baltimore. The 200,000 sq. ft. Harmans/BWI-1 facility includes 10 GMP suites, fill/finish operations, testing labs, and warehousing, while the 145,000… more
- Catalent Pharma Solutions (Chelsea, MA)
- …Specialist II is responsible for supporting daily operations in a GMP (Good Manufacturing Practices) Manufacturing Facility. This individual provides oversight of ... inspections conducted by external sources (ie health authorities). Support GMP manufacturing shifts as needed, including participation in shift change/floor… more
- Astrix Technology (New Brunswick, NJ)
- …water (PW) and Water for Injection (WFI) systems within a GMP -regulated biotechnology or biopharmaceutical manufacturing facility. This role ensures all water ... routine sampling, testing, and data logging of water systems in compliance with GMP and USP requirements. + Conduct preventive and corrective maintenance on water… more
- Lilly (Pleasant Prairie, WI)
- …role for routine production. This role will leverage a deep understanding of GMP data flows (electronic and paper), the application of data management and integrity ... production. This role will leverage a deep understanding of GMP data flows (electronic and paper), the application of...initiatives related to data integrity and data management for GMP information at the site: + Own site actions… more
- PCI Pharma Services (Bedford, NH)
- …improvement of the training program and courses to support all Cross Functional GMP stakeholders across PCI. The primary objective of the Training Specialist will be ... support the knowledge, skills and qualifications of the PCI operators. Maintain GMP training documentation to support personnel training needs via paper, training… more
- Actalent (Redmond, WA)
- …on manufacturing deviations and create deviation reports. + Maintain facility GMP compliance and assist in ensuring regulatory inspection readiness. + Collaborate ... and Drug Products. + Ability to understand and apply GMP regulations related to manufacturing. + Strong technical writing...investigations and root cause analysis in a pharmaceutical or FDA/ GMP environment. + Experience using GMP compliance… more
- Merck (De Soto, KS)
- …new biopharmaceutical facility in Desoto, KS. You will build GMP -compliant operations end to end-people, processes, and plant-while driving cross-functional ... operating procedures, batch records, and operational processes in alignment with GMP requirements. **_Team Development & Leadership_** + Recruit, hire, and develop… more