Supervisor Quality Control (Onsite) - 3rd shift

Core Hours: Tuesday - Saturday, 10:30 pm - 7:30 am

Purpose and Scope

Provide direct supervision of a team of analysts responsible for the testing and release of Tolmar products in support of manufacturing timelines.

Essential Duties & Responsibilities

• 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 which arise per the timelines specified in the department escalation strategy.
• Execute all business and department goals and initiatives on time.
• Ensure adherence for compliance with all processes and procedures including training completions, QE and CAPA due dates, notebook and logbook audits, archiving, schedules, internal assessments.
• Issue all Certificates of Analysis within 2 business days of last test completion.
• Generate, monitor and report weekly team and analyst KPIs.
• Supervise the testing and release of Tolmar products, cleaning samples, EM, Bioburden, Endotoxin, raw materials, and stability samples.
• Strive to balance workload across all sites and teams to ensure adequate resource allocation.
• Partner with the scheduler to schedule all testing and reviews, review the weekly schedule and ensure company and department targets are met in the shortest possible cycle time.
• Provide assistance, training and leadership for direct reports through utilization of the OTD resources.
• Create, revise and monitor training progress utilizing training matrices for immediate functional areas, and collaborate with team on remediation of training gaps for site training matrix.
• Set and communicate clear expectations for analysts including providing regular feedback and coaching, monitoring progress and fostering employee development to align individual and team performance with organization goals.
• Create and revise developmental plans to help employees grow their skills and advance their careers.
• Monitor and discuss progress of employee’s performance, growth and development in one on ones utilizing the career ladder and KPIs.
• Establish sample priorities for QC scheduler, submit schedule tickets as needed and ensure adherence to ship dates.
• Partner with the investigations team and the scheduler to ensure all actions for QEs are completed in 24 hours, second analyst testing is completed in less than 5 business days and QEs are closed on time (less than 45 business days).
• 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.
• Ensure all samples logged into the LIMS system are submitted correctly.
• 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.
• Aid in setting procedure and ensure that all operations and functions (including the laboratory) are in full FDA, cGMP compliance and staff is properly trained.
• Utilize senior analysts to assist in training, document updates, laboratory investigations, projects, or advanced technical issues.
• Conduct and coordinate laboratory investigations, and all associated actions.
• Review and approve technical reports, test methods, specifications and procedural documents and ensure overall validity of the analytical results and review stability reports.
• Participate in project teams, company and department meetings, third party audits, and regulatory audits.
• Monitor departmental spending to stay within the established budget.
• Demonstrate leadership aptitude in technical functions and people management.
• Ability to perform designated duties under minimal supervision and support departmental management in all aspects of organizational functions.
• Accountable for maintaining an atmosphere of teamwork, cordiality and respect towards co-workers.
• Accountable for meeting departmental and compliance timelines.
• Participate in required annual hazardous waste training. Hazardous waste involvement may include, but is not limited to, container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Participate in the interview and selection process for candidates, as required.
• Perform other duties as r