Quality Control RawMaterials and Lab Support Specialist

Job Title: Quality Control Raw Materials and Lab Support Specialist Location: Summit, NJ Duration: 12 Months Hybrid- 50% Onsite! Standard Hours; M-F Job Description This position (role) is responsible for supporting compliance and technical documents related activities in direct support of clinical and commercial CAR T manufacturing operations. This includes the ability to interface with cross functional groups, independently perform tasks such as technical writing/authoring of high-quality technical documents in support of incoming material release. Additionally, This Role will support various quality compliance responsibilities such as deviations, change management, quality events metrics, continuous improvements projects within the QC department. Author and revise GMP documents Author new documents used in the GMP test execution, including but not limited to material specifications, methods, justification of specifications, SOPs, protocols, and reports. Revise existing documents as needed. Manage the development of documents through the GMP document management systems. Assist in executing change controls where needed. Work with internal teams to obtainan in-depth understanding of the process and the documentation requirements. Produce high-quality documentation that meets applicable standards and is appropriate for its intended audience. Write easy-to-understand instructions where required. Create and maintain documentation projects and timelines. Provide excellent attention to detail in writings. Apply critical thinking skills when working out new procedures. Able to take direction from group members. Support End to End (E2E)Deviation/Investigations business process (From Initiation to Closure) As needed, assist to conduct thorough investigations (OOS, OOT, deviations, etc.) utilizing root cause analysis tools. Perform GEMBA walks with stakeholders to better understand process steps, and evaluate the need to make process improvements, with the coordination of Subject Matter Experts. Identify effective CAPAs, develop CAPA plans and assure CAPA effectiveness. Initiate change control documentation and assist other QC functional groups with change management documentation. Support impact assessments as part of the change management process. Support QC during audits and site inspections for QC compliance related inquiries. Support pulling and reporting quality metrics for department as needed. Performs other tasks as assigned. This position reports to Associate Director, Network Materials QC Must have Pharma/Biotech or Regulated Health Industry experience in GxP environment. Proven working experience inwriting/authoring Good Manufacturing Practices (GMP) documents as per Good Documentation Practices (GDPs). Ability to deliver a high volume of high-quality documentation, paying attention to detail. Ability to accurately and completely understand, follow, interpret, apply Global Regulatory and cGMP/GDPs requirements. Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures. Hands on experience on various Microsoft Office tools/applications Must have experience with electronic system (Track wise, Veeva etc.) Advanced ability to work in acollaborative team environment and train others. Ability to adapt to changing priorities and manage multiple assignments while meeting timelines. Good organizational skills and critical thinking skills. Ability to communicate honestly, transparently and effectively with peers, department management and cross functional peers. Education and Experience Bachelors degree required, preferable in Science, Advanced Degree preferred. At least 4 years of relevant work experience, preferable in a GxP regulated environment. An equivalent combination of education and experience is acceptable. This posting is for a contract assignment with ASK Staffing DBA ASK Consulting to provide services to Bristol Myer-Squibb . The starting hourly compensation for this assignment is the following range ( $25.08 - $29.08/ hr ). While the final, individual compensation and any available benefits will be determined by your employer of record ASK Staffing, Inc (and not BMS), factors that will be included in making the final determination may include the characteristics of the assignment #J-18808-Ljbffr Bristol Myers Squibb