Operations Supervisor
333 Phoenixville Pike Frazer, PA 19355 US
Job Description
Description:
Pay rate range: $38-40/hr
MUST have a degree and Must have GMP and Pharma Production experience. 3+ years administrative leading a team. Two years’ experience in a direct GMP manufacturing setting with demonstrated leadership skills Micronization Experience is a plus but not required. Education: Bachelor’s degree or higher 4-6 years in a regulated environment.
Micronization Experience is a plus but not required.
The Operations Supervisor is responsible for supervising site manufacturing operations, ensuring that all work completed is within timeframes /standards, holding self and team accountable for:
- Safety - Adherence to CMTI and industry safety standards. Serve as safety role model.
- Quality/Compliance - Adherence to CMTI Quality systems/cGMP
- Delivery - ensuring a timely flow and completion of micronization and milling jobs
- Cost - Ensure base cost and inventory management, process efficiency and resource utilization.
- People - Accomplish the sites goals work through themselves as well as through others while consistently modeling Catalent values and leadership competencies in all interactions.
- Directs production operators engaged in manufacturing activities by defining priorities, daily expectations and assignments ensuring a timely flow and completion of micronization and milling jobs
- Performs routine GEMBA on shop floor to ensure GMP & GDP adherence
- Communicates issues to the appropriate parties, shift status/transition issues to the following shift and cascading office/operations communications to staff as requested
- Technical review of BMRs, providing coaching and feedback to operators to achieve FIRST TIME RIGHT
- Ensures and validates the cleaning of the entire processing area and processing equipment
- Acts as a liaison between management and operators by effective communication/dissemination of information.
- Conducts manufacturing deviation investigations in trackwise
- Performs process operator duties when required
- Suggests process improvements to enhance efficiency and quality
- Participate in client audits and visits when requested.
- Demonstrates the ability to troubleshoot and perform basic repairs of systems and equipment
- Participates in the establishing/updating of Standard Operating Procedures (SOP).
- Completes special projects as assigned by the Operations Manager
- Perform Shop Floor inspection/check on going processing
- Willing and able to work weekends as needed
- Provides feedback and holds operations staff accountable
- Responsible for the on-time and thorough completion of all operator training requirements.
- Coaches staff on BMR completion with the goal as first time right
- Assist in operator selection/retention.
- Maintain positive employee relations.
- Maintains documentation on employee performance.
- Composes and delivers operator performance reviews.
- Administers employee discipline as required.
- Assist operators with quality resolution/improvement.
- Work with on floor QA support for any quality resolution
- Document Atypical Even in real time and initiate deviation within 24HR in Trackwise
- Ensures that product quality meets predetermined specification.
- Work with labs to ensure priority on sample testing
- Able to adjust to a changing production schedule.
- Ensures On Time Delivery.
- Submits data for production metrics.
- Ability to stand or walk for up to 8 hours per day.
- Ability to climb steps and ladders.
- Ability to lift up to 44 pounds as needed.
- Ability to wear a respirator and pass the required respiratory medical clearance.
- Ability to wear safety shoes when applicable.
Skills Requirements: Very good organizational skills
Computer - Email, Workday, Oracle.
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