Position Summary
The Production Downstream Lead directly leads the activities of the Operations in the Labeling/Packaging Production areas and serves as a first point of contact for manufacturing technical questions as well as trouble shooting and escalating matters to the Supervisor. The Production Downstream Lead ensures inspection, packaging, and labeling jobs have properly trained people. Also ensure procedures are executed accurately with the highest quality. The Production Downstream Lead helps ensure the production department meets applicable cGMP requirements and completes work on time per the production schedule.
Core Responsibilities
- Ensure production employees are adhering to ImprimisRx manufacturing standards and specifications.
- Must be able to review and advise on production batch records.
- Work with management to monitor operations throughout the shift, making the necessary adjustments in assignments to assure that the daily volume output Is achieved.
- Be trained and work into labeling and packaging rotation if required.
- Ensure that production schedule Is met by distributing workload in accordance with changing priorities by working in collaboration with Production Supervisors.
- Manage both physical board schedule and electronic schedules up to date for planning purposes across interdepartmental use.
- Ensure Interdepartmental spreadsheet is up to date with status of production per lot.
- Maintain metrics for labeling and packaging departments.
- Work with management to train new employees,
- Provide production management feedback for continuous Improvement.
- Support the Company's safety program to maximize safety awareness and provide a safe work environment.
- Assist In Evaluating /solving production problems by reviewing the area of concerns, developing potential solutions and recommendations for management.
- Supports continuous improvement by Identifying potential issues and driving to Improve work processes and procedures relative to manufacturing and/or filling and packaging equipment.
- Collaborate with Visual Inspection Department to assure continuity of vials being processed accordingly post inspection.
- Other additional duties as assigned.
Qualifications & Requirements
- High School diploma required; advanced degree preferred.
- Minimum of 1 -3 years' experience in a pharmaceutical manufacturing or medical device preferably In sterile environment.
- Ability and willingness to work and participate effectively in a team environment.
- Attention to detail, safety, quality and departmental requirements.
- Ability to effectively communicate verbally and in writing to subordinates, peers and management.
- Ability to read information and apply what Is described in the reading material to situations that may contain several details or describe processes involving several steps.
- Demonstrate high level of personal motivation and initiative.
Position Type