Production Supervisor, 2nd​/3rd shift; OSD

Overview

Production Supervisor, 2nd/3rd shift (OSD Experience required) at Granules Pharmaceuticals, Inc. The role is responsible for daily coordination and execution of working schedules of people and equipment in the Production line, supervising operators across Granulation, Drying, Blending, Compression, Pellet coating, Tablet coating and Encapsulation of drug products while meeting department quality, safety, delivery, and productivity objectives. Supervisors are knowledgeable in cGMPs and good manufacturing practices, with strong documentation, production planning, and labor utilization skills.

• Oversees hourly operators in execution of daily work; ensures compliance with validated parameters and standard operating procedures
• Develops daily/weekly department work schedules, sets priorities, and verifies resource availability
• Manages schedule adherence; participates in scheduling meetings to increase resource utilization
• Adapts to changes in daily workflow and redeploys resources/overtime to meet delivery and customer service commitments; responds to unplanned maintenance or investigations
• Ensures all equipment is functioning properly
• Reviews batch records and supporting records prior to submission to Quality
• Maintains a safe work environment
• Performs in-process checks and verifications in alignment with SOPs

• Adheres to good documentation practices (GDP)
• Executes Quality Management System assignments (CAPA, Deviation, Change Control, SOPs) to on-time closure
• Gathers knowledge and executes assignments in QMS areas: deviation management and/or change control
• Acts on investigations for root cause, determines corrective actions, writes reports, and ensures timely closure
• Initiates and executes change control assignments to support continuous improvement for equipment, documentation, or processes
• Initiates work orders for equipment repairs or modifications
• Creates, reviews, and conducts operator training programs on SOPs, cGMP, and safety; ensures proper documentation
• Supports classroom and hands-on training for batch records, SOPs, and cGMPs
• Complies with Safety policies and OSHA regulations; participates in safety meetings and corrective actions

• Reports production updates and schedule changes during daily meetings
• Ensures operators comply with procedures, GMP, safety, and contract obligations; provides feedback
• Assigns manpower; documents violations and disciplinary actions as required
• Requests equipment and facility repairs or modifications
• Understands and complies with Union Agreement
• Keeps management informed of operations; elevates as needed

• Reviews operational performance and drives improvement opportunities
• Counsels, trains, and develops union colleagues for efficient performance; promotes teamwork and open communication
• Enforces SOPs and company policies consistently
• Troubleshoots issues impeding department objectives; demonstrates ownership to achieve results
• Interfaces with equipment suppliers and area consultants
• Supports audits and inspections by CMOs or regulatory agencies

• Required – B.A. / B.S. in Science, Business or related field or significant experience
• Desired – B.A. / B.S. in Pharmaceutical Sciences, Business Management or related area

• 5+ years in a supervisory role within Pharmaceutical Manufacturing, Operations, or Quality with increasing responsibility
• Experience in OSD Manufacturing with increasing responsibility

• Knowledge of Quality Management Systems, Document Management Systems, and MS Office
• Solid understanding of current state, federal and local standards and regulations (cGMP, OSHA, FDA, DEA)