Position Scope:
The Packaging Supervisor is responsible for ensuring the scheduling, execution, and completion of activities in an ISO 13485 packaging environment ensuring safety, quality, compliance, delivery and cost are maintained on the packaging floor.
Specific Responsibilities:
- Supervise work activities ensuring compliance to standard operating procedures in accordance to cGMP guidelines and other regulatory standards
- Supervise employees including setting daily goals, participating in employee reviews, and establishing employee development plans
- Ensure reporting team members are fully trained across all areas including operating equipment, health, safety and environmental procedures, quality checks and systems
- Identifies and investigates any Health and Safety or Quality concerns, addressing behavior to prevent future problems
- Improves performance through coaching, leadership, and training on Manufacturing, Lean, and Continuous Improvement principles
- Analyzes production system data to access root cause of problems including downtime, product failure and ways to increase efficiency; recommend and implement measures that result in continuous improvement in the packaging process
- Complete root cause analysis using tools such as Fishbone and/or RACI
- Responsible for shift scheduling to include: work station assignments/rotations, employee training, employee break management, overtime assignment, back up for absent employees, and shift rotations
- Develop, revise, and implement Standard Operating Procedures (SOP) as needed
- Supervise ERP inventory transactions, ensure inventory levels and initiate procurement of various operating supplies in the faculty
- Coordinate preventative maintenance and calibration activities/requirements to ensure minimum costs and prevent operational delays
- Direct and coordinate various programmers essential to packaging procedures (e.g. training, safety, housekeeping, cost reduction, etc.)
- Lead the smooth transfer of new packaging developments into commercial operations and ensure that the staff is fully trained in both the process technologies and key process parameters relevant to all new products
- Ensure breaks and lunches are being given at the appropriate times and in accordance with laws
Job Complexity:
The position works on equipment and assignments where adherence to proper safety and cGMP procedure is required in order to perform work activities. Complexity requires the ability to think quickly on the packaging floor.
Required Qualifications:
- Bachelor's degree preferred or Associates degree and equivalent work experience
- A minimum of 5 years of experience supervising Packaging operations (medical device/pharmaceutical experience preferred) or
- 6 years of progressive packaging operations experience in medical device/pharmaceutical, including 2 years of experience as a Lead
- In depth knowledge of Microsoft Products and ERP systems required
- Excellent time management and communication skills
Desired Experience, Knowledge, and Skills:
- Experience leading daily improvement huddles focusing on Safety, Quality, Compliance, Delivery, and Cost
- Proficient in SAP transactions, cycle counting, physical inventory, and maintaining spreadsheets
- Leader of Operational Readiness floor activities for the transfer of new packaging lines and products