- Amgen (Thousand Oaks, CA)
- …of the Amgen team. Join us and transform the lives of patients while transforming your career. ** Deviation / CAPA Site SME ** **What you will do** Let's do ... as well as participating in, or leading, process improvements. + Own site /function NCs, CAPA /EVs, and change records for process + Develops and owns site… more
- Bristol Myers Squibb (Summit, NJ)
- …control process/ procedures. + May support health agency inspection as equipment area subject matter expert . + Communicate effectively with management and ... CAPAs and change controls. + Perform document revision, project, CAPA and deviation / investigation, change mgmt. actions,...experience. Eligibility for specific benefits listed on our careers site may vary based on the job and location.… more
- Lilly (Indianapolis, IN)
- …the future of manufacturing excellence at Eli Lilly! **Key Objectives and Deliverables:** **Technical Subject Matter Expert ( SME ) Oversight** : + ... to maintain the reliable supply for products across the site . Embrace the challenge, seize the opportunity, and join...events and work on the identification and implementation of CAPA plans to address such events and prevent recurrence.… more
- Lilly (Indianapolis, IN)
- …supply for products across the site . **Key Objectives and Deliverables:** **Technical Subject Matter Expert ( SME ) Oversight** : + Demonstrate ... technology transfer agenda, ensuring seamless integration and replication of Site business and Quality Systems for Commercial Launch/Technical Agenda activities.… more
- BD (Becton, Dickinson and Company) (Brea, CA)
- …projects relevant to the business. + Act as a subject matter expert ( SME ) at the site and functional level. **Qualifications** * Bachelor's degree ... resource allocation, and administration. + Support the Corrective and Preventive Action ( CAPA ) process. + Lead a team of Quality Managers and Engineers, operating… more
- Bristol Myers Squibb (Devens, MA)
- … experts for product impact and justification to continue manufacturing. + Serve as a subject matter expert supporting others to navigate the BMS quality ... is responsible for 24x7 Quality collaboration and oversight of site operations, including but not limited to Manufacturing, Quality...management system including but not limited to deviation and CAPA action management, interim production… more
- Lilly (Pleasant Prairie, WI)
- …Engineer will join the Utilities, Facilities, and Project Engineering team as the site Subject Matter Expert ( SME ) at the Lilly Kenosha County (LKC) ... campus for site HVAC (GMP and Non-GMP) and Utilities systems, both...systems associated within their facilities. **Responsibilities:** + Be the SME with a deep technical expertise in all systems… more
- Boehringer Ingelheim (Athens, GA)
- …validation documents. This position serves as a subject matter expert for internal and external department/ site and global projects. **Duties & ... This includes, but is not limited to, contractor oversight, document review, deviation management and CAPA assessment, as applicable. Provide department… more
- Astellas Pharma (Westborough, MA)
- …+ Previous experience interacting with regulatory agencies, representing technical deliverables as a subject matter expert , audit hosting / support, etc. ... risk-based decisions, and exercise sound Quality-by-Design principles. + Fluency in Deviation investigation techniques, root cause analysis methods, CAPA … more
- WuXi AppTec (Middletown, DE)
- …collaboration with Manufacturing, QA, Engineering, and Supply Chain. Technical Leadership * Serve as subject matter expert ( SME ) for QC operations, ... oversee all QC operations for WuXi STA's new DE site . The QC Director will lead all Quality Control...method validations, and method transfers. * Lead or approve deviation investigations, root cause analyses, and CAPA … more
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