Quality Control Scientist - NMR

Core

Hours:

Monday - Friday 8:00am - 5:00pm

The Quality Control Scientist I - NMR is a technical leader within the QC functional area with a primary role in scientific development, testing and mentoring of junior analysts. The role is intended for a person with significant pharmaceutical laboratory experience who will contribute product specific scientific knowledge and analytical skills to the QC group.

• Assume a high level, in-depth scientific leadership and mentoring role in the QC laboratory for junior analysts and peers. Such a role may entail training and mentoring of new hires, dissemination of product specific knowledge to the QC group and technical leadership in specific projects as assigned.
• Conduct complex and challenging QC testing using a variety of instrumentation that needs a high level of analytical technical expertise and in-depth knowledge in chemistry garnered from prior employment experience or academic training.
• Expert in the analysis, utilization, safety and troubleshooting of NMR instrumentation and NMR method development.
• Act as a primary technical resource for and be a point of contact for QC and external departments.
• In depth subject matter expertise in a variety of types of routine instrumentation including NMR, HPLC, GC, FTIR, FTNIR, water content and associated software systems like Chromeleon or Empower.
• On assignment by management, possesses the ability to resolve testing issues including Out of Specifications and investigations for commercial, stability and developmental samples.
• Provide scientific recommendations and technical expertise for new instrumentation and methodology that may be introduced in the QCC department.
• Make scientific recommendations to management and other departments regarding Quality Control laboratory protocols and test procedures. Assist laboratory management in test assignments based on commercial and stability time lines and provide hands‑on testing support during commercial exigencies.
• Assist the departmental leadership in new endeavors including efficiency efforts, organizational tasks, and non‑routine activities that require a higher level of scientific skills.
• Upon delegation, assume a supporting role to the management team on activities such as the issuance of COA’s, review of Change controls, test methods and specifications.
• Provide support to the QC department for the evaluation and implementation of new technological innovations in laboratory automation systems, documentation systems and other technologies.
• Perform change assessments and change controls for changes in testing, documents and specifications.
• Validate and install new laboratory instrumentation systems including development of new test methods for the associated instrumentation.
• Serve as a project team member and collaborate with CORE teams throughout the development lifecycle.
• Prioritize workload to meet timelines while ensuring on‑time delivery of all projects, testing and action items.
• Take ownership of tasks and results from initiation to completion to meet commitments and proactively address outcomes.
• Escalate and communicate items that arise per the timelines specified in the department escalation strategy.
• Execute all business and department goals and initiatives on time.
• Support and execute all potential 3‑day field alert investigations and actions expeditiously.
• Submit document change requests for all document updates and minimize document revisions for routine updates where possible.
• Identify, and complete cost savings initiatives and facilitate continuous improvement.
• Participate in leadership development activities and take an active role during department and company activities.
• Participate on project teams, company and department meetings, third party audits, and regulatory audits.
• Demonstrate leadership aptitude in technical functions.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Ensure adherence for compliance with all processes and procedures including training completions, QE and CAPA due dates, notebook and logbook audits,…