Location: Buena, NJ
sponsible for providing leadership and direction to the filling and packaging of Topical products (creams, ointments, lotions, solutions) ensuring product compliance to established current Good Manufacturing Practices (cGMPs), customer requirements and in conjunction with all Standard Operating Procedures (SOPs). Follows standard operating procedures to complete tasks, some of which may vary in scope, sequence, complexity and timing. Applies skills and knowledge to recognize process issues and to increase efficiency, throughput and quality. Troubleshoots process, equipment issues and, as a team member, analyzes root causes and makes recommendations.
- Ensures compliance with GMP, SOPs, Quality and Safety requirements and leads coordination of activities of Filling and Packaging associates to meet daily operations requirement.
- Assures packaging batch records are reviewed, corrected and submitted to Quality Assurance.
- Coordinate temporary and permanent labor to staff the line as per standards.
- Provide accurate production standard inputs to the Operations Supervisor as it pertains to filling/packaging.
- Ensures that all the necessary reconciliations for components and parts are completed in SAP in a timely manner.
- Complete all necessary component transactions and job requisitions are completed and uploaded in SAP.
- Acts as liaison between filling/packaging personnel and the Operations Supervisor.
- Ensures timely communication of incidents related to Safety and Quality (process deviations/notice of events) to management.
- Actively involved in investigating process deviations, notice of events and placing appropriate corrective action and preventative actions (CAPA)
- Adhere to best practices for the department in accordance to government regulatory and quality standards while meeting department goals and objectives.
- Operate filling and packaging machinery which includes start-up, equipment set-up, filling, changeover, cleaning and sanitization.
- Execute written SOP’s to ensure the purity of materials involved in the filling and packaging process.
- Batch Production Record (BPR) and logbook documentation with detail and accuracy as it applies to job function in real time.
- Demonstrate behaviors related to safety, quality, and production.
- Follow and adhere to all cGMPs, compliance/regulatory mandates, SOP’s and quality requirements.
- Identify and communicate processing related issues to the area management.
- Collaborate with colleagues from the same and other departments such as manufacturing, quality, maintenance, and the laboratory.
- Other duties as assigned.
- Minimum high school diploma or GED with a minimum of 2 to 3 years of experience working in a Pharmaceutical environment. (Preferably in filling of topical dosage form or in Medical Device Industry).
- Demonstrated ability to work with minimal supervision and the ability to read and understand written procedures and instructions.
- Demonstrated ability to work in a team environment with excellent communication skills.
- Demonstrated ability to lead peers and coworkers.
- Experience in a clean room environment and best practices.
- Demonstrated ability to perform basic math (add, subtract, multiply, divide, weights & measures).
- While performing the duties of this job, the employee is regularly required to stand, up to 12 hours. The employee is frequently required to walk; sit; use hands; talk; and hear. The employee is occasionally required to reach with hands and arms; climb or balance; stoop; kneel; crouch. The employee must occasionally lift and or move up to 50 pounds. Must be able to stand for long periods of time, up to 12 hours. Must be able to wear specific PPE. Vision abilities required by this job include close vision, distance vision, and color vision.
- The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
This job description is not all-inclusive. It acts as a guideline and is subject to change over time. Additional duties may be assigned based on business needs