Production Downstream Lead

Harrow, Inc.•Roxbury Township, NJ

3d•Onsite

About The Position

The Production Downstream Lead directly leads Operations activities in the Labeling and Packaging Production areas. The role is a first point of contact for manufacturing technical questions, troubleshooting issues, and escalating matters to the Supervisor. The Lead ensures inspection, packaging, and labeling jobs are staffed by properly trained employees and that procedures are followed accurately and with the highest quality. The position helps ensure the production department meets applicable cGMP requirements and completes work on time according to the production schedule.

Requirements

High school diploma required.
Minimum of 1–3 years of experience in pharmaceutical manufacturing or medical device manufacturing, preferably in a sterile environment.
Ability and willingness to work and participate effectively in a team environment.
Attention to detail, safety, quality, and departmental requirements.
Ability to communicate effectively verbally and in writing with subordinates, peers, and management.
Ability to read information and apply it to situations involving multiple details or steps.
Demonstrate a high level of personal motivation and initiative.

Nice To Haves

Advanced degree preferred.

Responsibilities

Ensure production employees adhere to ImprimisRx manufacturing standards and specifications.
Review and advise on production batch records.
Work with management to monitor operations throughout the shift and adjust assignments as needed to achieve daily volume output.
Train and work in the labeling and packaging rotation when required.
Meet the production schedule by distributing workload according to changing priorities in collaboration with Production Supervisors.
Maintain current physical board and electronic schedules for planning across departments.
Keep the interdepartmental spreadsheet updated with production status by lot.
Maintain labeling and packaging department metrics.
Work with management to train new employees.
Provide production management with feedback for continuous improvement.
Support the Company’s safety program to maximize safety awareness and provide a safe work environment.
Assist in evaluating and solving production problems by reviewing areas of concern and developing potential solutions and recommendations for management.
Identify potential issues and drive improvements to work processes and procedures related to manufacturing and/or filling and packaging equipment.
Collaborate with the Visual Inspection Department to ensure continuity of vials being processed after inspection.
Perform other additional duties as assigned.