Technical Operations Supervisor - Kelly Science, Engineering, Technology & Telecom : Job Details

Kelly Science & Clinical is seeking a Supervisor - Technical Operations in Northbrook, IL.

Direct Hire

Shift: Monday - Friday 8am-5pm

Compensation: $70,000 - $120,000/year DOE

Position Summary

The Technical Operations Supervisor will be responsible for overseeing the Investigations workflow, primarily supporting Manufacturing and Technical Support reagent system performance investigations. This role requires executing and managing cross-functional investigations, affecting product disposition, implementing product Corrective and Preventive Actions (CAPA), and process changes. The supervisor will demonstrate both direct and indirect leadership while collaborating closely with key departments such as Quality Management, Regulatory, Manufacturing, and Technical Services.

Key Duties and Responsibilities

• Supervise a team of scientists with advanced technical skill sets.
• Manage and ensure accountability for tracking Key Performance Indicators (KPIs) related to Quality Notifications, CAPAs, and Technical Complaints, leveraging data to enhance investigational process efficiencies.
• Lead and prioritize projects for the Investigations team.
• Understand troubleshooting immunoassays, quality control systems, and quality management systems.
• Align business priorities with strategic organizational direction.
• Develop and mentor employees to become independent investigators.
• Act as a Subject Matter Expert (SME) for tracking and trending consultations and for developing change plans.
• Independently own investigation processes.
• Manage Work In Progress (WIP) failure mitigations, including technical and quality disposition functions.
• Review and optimize Product Quality Control systems within Manufacturing.
• Document Engineering Change Orders (ECOs), validation plans/reports, and Planned/Non-conforming Quality Deviations.
• Serve as a SME for product and process risk management.
• Conduct Technical Support confirmatory testing.
• Handle new equipment Installation Qualification (IQ), Operational Qualification (OQ), Performance Qualification (PQ), and transfer of equipment to Manufacturing.
• Contribute to the annual work center budget.
• Ensure comprehension of competitive and sandwich immunoassays and differentiate between quantitative and qualitative immunoassays. Specific assay knowledge will be acquired during investigations.

Education, Experience, and Qualifications

• Bachelor's degree required.
• Minimum of 5 years of experience in a regulated industry.
• Demonstrated expertise in validation plan/report creation and risk-based validation.
• Proven ability to work independently.
• Expert knowledge of laboratory and manufacturing equipment and processes.
• Comprehensive understanding of immunology and immunoassay technology and systems.
• Ability to supervise a team of 3-7 Scientists.
• Develop leadership competencies and create a motivated, knowledgeable, and accountable support group environment.
• Foster open channels of communication throughout the organization.
• Cultivate trusting relationships and ethical leadership through interactions.
• Possess problem-solving skills to diagnose issues, resolve key problems, and implement resolutions effectively.