QC Chemistry Supervisor, 2nd Shift

Key Responsibilities

• Oversee physical, chemical, and microbiological testing of raw materials, in-process materials, finished products, stability samples, and special project samples.
• Ensure testing is completed in accordance with approved procedures and established timelines.
• Capture and manage testing performed by external contract laboratories.
• Schedule laboratory activities and allocate resources to meet production and project commitments.
• Perform and oversee data review and auditing activities supporting product disposition decisions.

Investigations & Compliance

• Lead laboratory investigations, including Out-of-Specification (OOS), Out-of-Trend (OOT), deviations, and laboratory events.
• Support method validation, method verification, and technology transfer activities for new and existing products.
• Prepare, review, and approve validation and verification protocols and reports.
• Drive audit readiness initiatives to maintain a continuous state of inspection preparedness.
• Monitor laboratory systems, procedures, and practices to ensure compliance with GMP, regulatory, and internal quality requirements.

Leadership & People Management

• Provide leadership, coaching, and development opportunities for QC analysts and laboratory staff.
• Establish individual and team performance objectives aligned with departmental goals.
• Conduct performance reviews, talent assessments, and merit recommendations.
• Participate in recruiting, interviewing, and onboarding qualified laboratory personnel.
• Ensure appropriate technical, compliance, and safety training programs are executed.

Continuous Improvement & Project Support

• Lead initiatives focused on quality, operational efficiency, and process improvement.
• Represent Quality Control on cross-functional site projects and improvement teams.
• Support implementation of laboratory systems and strategic initiatives, including:
• Laboratory Information Management Systems (LIMS)
• TrackWise
• Equipment qualification activities (IQ/OQ/PQ)
• Laboratory modernization projects
• Identify opportunities to enhance laboratory productivity, compliance, and customer service.