What are the responsibilities and job description for the Manufacturing Clerk position at AAA Pharmaceutical, Inc.?
JOB SUMMARY
The Manufacturing Clerk is responsible for providing clerical support the operations at the Paulsboro facility.
A strong understanding of the facility?s activities, along with relevant procedures, is required to effectively execute this role. Position must provide efficient oversight and direction to operations personnel, assistance to QA personnel, perform maintenance tasks, manage inventory stocks, manage shipping/receiving, maintain facility cleanliness and coordinate with the Lumberton facility and external vendors.
Work under general supervision following company policies and ensuring compliance with cGMPs, FDA, OSHA and other applicable regulatory jurisdictions.
Maintain direct communication with management to provide necessary clerical support the facility to maintain a ready status at all times, capability, and ensure that any necessary support / resources are communicated.
1. Perform Warehouse Duties. Work with minimal supervision, while performing tasks in a safe and timely manner.
A. Inventory Management:
- Maintain inventories of Raw materials, Consumables and Spare Parts:
- Work with blending operators to maintain a visual inventory Kanban for raw materials.
- Report Weekly Consumable inventory to Lumberton and submit supply request to maintain appropriate levels.
- Routinely monitor consumption of spare parts to ensure appropriate inventory is maintained for continuity of operations.
- Identify and train staff, as appropriate.
- Perform appropriate transactions in Facility Dude? application.
B. Shipping & Receiving:
- Coordinate planned shipments/receipts with Lumberton (warehouse, QA & production coordinator) and external shippers.
- Prepare items for transfer/shipment.
- Oversee dock operations to safe and damage-free transfers.
- Stage outgoing items for efficient transfers, while avoiding impact to production material flows.
- Store incoming items, in a timely manner to minimize impact to production operations.
- Perform weekly powered pallet jack inspection.
- Serve as back-up truck driver.
- Identify and train staff, as appropriate.
2. Perform Facility Maintenance Duties. Work with minimal supervision, while performing maintenance and repair activities in a timely manner.
- Document required repairs/breakdowns in the Facility Dude? application.
- Perform scheduled PMs and complete documentation in the Facility Dude?.
- Assess and perform necessary repairs to ensure continuity of operations (communicate any necessary external resources.
- Coordinate external resources for scheduled maintenance.
- Communicate directly with Lumberton mechanics to ensure necessary details are provided.
- Manage inventories of items/materials critical to facility & equipment maintenance.
- Provide direction to custodial/support personnel to maintain facility in an audit-ready state.
- Generate and maintain a facility punch-list of repair maintenance items that would require support from external contractors.
3. Perform Operations Duties. Work with minimal supervision, while performing tasks in a compliant manner.
- Oversee daily manufacturing operations and facility efficiency of activities/personnel.
- As necessary, operate equipment during absence of scheduled operators.
- Assist with troubleshooting activities.
- Provide routine communication of finished product batches that are available for transfer.
- As necessary, provide / transmit production related information to the production coordinator.
- Manage custodial/support personnel performance of portable hopper transfers.
- Routinely monitor and review shift logs for content completeness and accuracy.
4. Support QA Activities. Work with minimal supervision, while performing tasks in a qualitative manner.
- Support QA staff with resolution of issues/concerns.
- Perform GMP walkthrough and Safety checklists.
- Routinely monitor and review log books for content, completeness and accuracy.
- Assist QA with the necessary details to generate thorough Incident Reports.
- As necessary, perform QA In-Process inspection duties during absence of scheduled QA staff.
- Manage GMP training for Paulsboro personnel.
- Support audit preparation activities