Quality Operations Supervisor ( 1st shift SHIFT - M-F 6AM - 2:30PM)
333 Phoenixville Pike Frazer, PA 19355 US
Education or Equivalent/Experience:
Bachelors degree or higher 4-6 years in a regulated environment. 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.
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 Client values and leadership competencies in all interactions.
II. Specific Activities, and Responsibilities Operations
- 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
Scheduling and Reporting
- 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.
Very good organizational skills
Computer - Email, Workday, Oracle.
36-42 pay rate range
**salary will be commensurate with experience**
Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.