Inspection & Packaging Supervisor
hace 16 días
Langhorne
Job Description Inspection & Packaging Supervisor Penn Life Sciences – Langhorne, PA Penn Life Sciences (PLS) is a rapidly growing sterile injectable manufacturer committed to delivering safe, high-quality pharmaceutical products. We are seeking a driven Inspection & Packaging Supervisor to oversee our visual inspection and packaging operations. This role is critical to ensuring product quality, compliance, and operational efficiency, while developing and leading a strong team. Role Purpose * Lead and manage visual inspection and packaging operations in compliance with cGMP and regulatory standards. * Ensure inspection qualification programs (defect kits, inspector performance) are effectively maintained and documented. * Oversee daily packaging activities including serialization, aggregation, labeling, and shipping preparation. * Develop staffing plans, schedules, and workload distribution to support uninterrupted operations. * Drive achievement of departmental metrics such as changeover times, output per shift, and defect detection rates. * Provide coaching, training, and development opportunities to inspection and packaging staff. * Implement continuous improvement initiatives to increase efficiency, reduce documentation errors, and strengthen compliance. * Collaborate with cross-functional partners (Quality, Engineering, Validation, Supply Chain) to resolve issues and support audits. Key Duties & Responsibilities * Develop staffing plans and schedule resources to support inspection and packaging operations. * Lead, coach, and train employees through regular 1:1s, cross-training, and performance development. * Monitor and communicate key metrics such as line speed attainment, output per shift, and changeover performance. * Oversee inspection qualification programs, including defect kit management and inspector testing. * Supervise packaging operations, ensuring compliance with serialization, aggregation, and labeling requirements. * Manage AQL/AOQL sampling with QA to ensure compliant lot disposition. * Investigate and resolve deviations, nonconformities, and documentation errors. * Drive continuous improvement initiatives to optimize efficiency and strengthen compliance. * Support regulatory and customer audits with accurate documentation and process oversight. Supervisory Responsibility * Direct supervision of inspection and packaging staff. * Responsible for scheduling, training, performance reviews, and staff development. * Foster a culture of accountability, safety, quality, and continuous improvement. Education & Experience * Bachelor’s degree in Life Sciences, Pharmaceutical Sciences, Engineering, or related field preferred; equivalent experience will be considered. * 5–10+ years of experience in a cGMP pharmaceutical or biopharmaceutical environment. * Strong background in visual inspection of sterile injectable products required. * Hands-on experience in packaging operations including serialization and aggregation. * Demonstrated leadership or supervisory experience in a regulated manufacturing setting. * Experience with AQL/AOQL sampling, documentation systems, and regulatory audits. * Proficiency with MES/ERP systems and Microsoft Office. Technical Competencies * Knowledge of cGMP, FDA/EMA regulations, and aseptic processing requirements. * Expertise in inspection qualification, defect kits, and defect recognition. * Strong understanding of packaging operations, serialization, and aggregation. * Ability to analyze and manage departmental metrics and quality sampling results. * Skilled in documentation, deviation management, CAPA, and change control. * Strong leadership, training, and team development skills. * Effective problem-solving and decision-making under production demands. Physical Demands * Ability to stand and walk for extended periods. * Perform fine visual and manual tasks requiring strong visual acuity and color discrimination. * Lift and move materials up to 40 lbs safely. * Frequent reaching, bending, and handling of packaging components. * Regular use of PPE and sterile gowning in controlled environments. Work Environment This role is performed in a cleanroom and controlled manufacturing environment under cGMP regulations. The position requires strict adherence to gowning procedures, sterile practices, and safety protocols. Work involves interaction with cross-functional teams and may require flexibility in schedule, including evenings, weekends, or overtime, to meet production needs. Company DescriptionPenn Life SciencesPenn Life Sciences