Job Description
About KVK Tech
KVK Tech is a U.S.-based generic and specialty pharmaceutical manufacturer committed to developing and producing high-quality, FDA-approved medicines that improve patients’ lives through accessibility and trust. Headquartered in Newtown, Pennsylvania, KVK Tech maintains all operations within the United States, ensuring quality and consistency through strict adherence to cGMP standards and regulatory compliance. Our commitment to excellence is reflected in our precision, reliability, and shared mission to provide safe, affordable, and life-improving pharmaceutical products.
What You’ll Do
The Assistant Manager, Packaging supports the Packaging Manager in leading the daily operations of the Packaging Department within a regulated oral solid dosage pharmaceutical manufacturing environment. This role provides operational leadership across packaging shifts, lines, and personnel to ensure production schedules are achieved safely, efficiently, and in compliance with cGMP, FDA, DEA, OSHA, and company requirements. The Assistant Manager coordinates closely with Packaging Supervisors and cross-functional departments, supports employee development and performance management, and serves as a designated departmental leader in the Packaging Manager’s absence.
Key Responsibilities:
- Support the Packaging Manager in overseeing daily packaging operations and ensuring compliance with approved procedures, cGMP requirements, safety standards, and production expectations.
- Provide leadership and direction to Packaging Supervisors and other packaging personnel across assigned shifts, lines, or operational areas.
- Coordinate daily and weekly packaging schedules, staffing assignments, material readiness, equipment availability, and production priorities.
- Monitor packaging line performance, schedule attainment, labor utilization, downtime, waste, and other departmental performance indicators.
- Review packaging batch records, logbooks, reconciliation records, cleaning documentation, and production reports for accuracy, completeness, and timely completion.
- Collaborate with Quality Assurance, Manufacturing, Warehouse, Shipping, Engineering, Maintenance, and other departments to resolve issues and maintain production flow.
- Support packaging-related deviations, investigations, CAPAs, change controls, root cause analyses, and other Quality System activities.
- Identify recurring production issues and implement or recommend process improvements to increase efficiency, reduce downtime, and minimize waste.
- Coach and develop Packaging Supervisors, Line Leaders, Operators, Material Handlers, and Mechanics to strengthen performance, accountability, technical capability, and compliance.
- Ensure packaging personnel receive required training on SOPs, cGMP, ALCOA+, data integrity, safety procedures, equipment operation, and departmental expectations.
- Assist with employee performance management, attendance concerns, coaching, corrective actions, and staffing recommendations in coordination with the Packaging Manager and Human Resources.
- Support new product introductions, packaging line trials, equipment qualifications, process validations, and continuous improvement initiatives.
- Ensure packaging information is entered accurately and timely into ERP and production reporting systems.
- Prepare and communicate production updates, performance metrics, staffing concerns, operational risks, and departmental priorities to management.
- Support internal audits and regulatory inspections by maintaining inspection readiness and assisting with document retrieval and operational walkthroughs.
- Serve as the designated departmental leader in the absence of the Packaging Manager within assigned authority.
What We’re Looking For
Experience:
- Minimum of 6–9 years of progressive experience in pharmaceutical packaging, pharmaceutical manufacturing, or another cGMP-regulated production environment.
- Minimum of 2–3 years of leadership, supervisory, or management experience overseeing production employees, packaging lines, or manufacturing operations.
- Demonstrated experience coordinating production schedules, staffing, equipment availability, material readiness, and cross-functional operational support.
- Experience reviewing batch records, reconciliation records, production documentation, and packaging performance data.
- Experience supporting deviations, investigations, CAPAs, change controls, equipment qual