Process Coordinator - 2nd Shift
- College degree preferred or High School diploma
- Previous experience as Process Setup Attendant or Quality Auditor preferred.
- Must be able to read, write and communicate in English.
- Must have strong communication, problem solving, troubleshooting and multi-tasking skills.
- Display strong math skills (addition, subtraction, percentages, averages).
- Proficient computer skills. (SAP, TML, Office).
- Must be detail oriented.
- Demonstrated leadership and interpersonal skills.
- Lead the Line Team to achieve efficient Production Runs and Changeovers.
- Ability to lift 35 pounds.
- Required to have and maintain a good attendance record.
- Required to work in all Work centers in Production.
- Able to work overtime.
- Work with the Quality Specialists to ensure completeness and P.O. folder closure.
- Adhere to all SOP Guidelines and Golden Rules pertaining to Company Policies.
- Collaborate and work with Supporting Departments to meet our department goals.
- Able to perform other duties assigned (e.g taking attendance, etc).
- Complies with all prescribed Safety and GMP procedures.
- Mentor crew members to utilize proper ergonomic related equipment (Drum lifters)
- Proactively address or report any necessary safety related issues or concerns.
- Mentor crew members to follow all policies and procedures (recycling, PPE, etc.).
- Rotate all members of line according to work instructions for each job as required.
- Engage in site wide safety programs.
- Responsible for addressing any safety concerns to prevent work related injuries.
- Follow cGMP and corporate quality SOPs at all times.
- Accurately perform and document quality inspections required by assembly instructions.
- Ensure accuracy of components, both quantity and quality to start job and when returning components.
- Assign line tasks per productivity guidelines and communicate all quality instructions.
- When quality issues arise, communicate with QA management for batch information and proper actioning
- Initiate and follow up on potential QA holds and control stagnant inventory.
- Maintain a clean and orderly work area and adhere to all GMP and Regulatory Guidelines.
- Ensure all team members in assigned resources follow GMP compliance.
- Work with your off-shift counterparts to have any errors corrected in a timely fashion and following GDP guidelines.
- Ensure accurate inputs, confirmations into SAP and investigate any inventory discrepancies and variances
- Monitor hopper and componentry levels with mechanics/TOs to manage and reduce scrap at end of run
- Responsible for performing final batch record review and all associated tasks completely and accurately with SOP and GDP guidelines
- Provide and communicate detailed cross over information during shift change to next shift.
- Proactively prepare for the next shift counterparts for a smooth shift hand-off and successful shift
- Proactively prepare for the next production runs to ensure smooth and faster changeovers
- Assist and train fellow co-workers and temporary employees.
- Maintain control of the Batch Records and their content to ensure compliance and timely approval
- Verify, monitor, and document line efficiency goals for each job as assigned.
- Accurately perform line clearance and assist with changeover process.
- Lead the Line team to achieve efficient Production Runs and Changeovers
- Record hourly counts and detailed downtime information in TML
- Collaborate with Opex Engineers to provide insight into root cause analysis
- Actively participate and support facility and corporate Lean Manufacturing initiatives including but not limited to: Value Stream Mapping, and Kaizen events.
- Be engaged with initiatives, projects and drive sustainability
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