Dynamic Cleanroom Operator with extensive experience at Integra LifeSciences, adept at ensuring compliance with GMP and ISO standards. Trilingual in English, French, and Spanish, I excel in strategic planning and analytical decision-making, consistently achieving inventory accuracy and operational efficiency. Proven ability to manage complex tasks while maintaining a clean and organized work environment.
To perform this job successfully, an individual must be able to perform each essential duty satisfactory.
Work with internal and external parties to insure the proper items are received in a timely manner and documented.
Verifies all incoming materials and paperwork against purchase orders, notifies Buyer of any missing documentation, damages, shortages, and problem receipts.
Performs receipt transactions and material moves ensuring receipt and inventory accuracy in ORACLE.
Process all required receiving paperwork; affix all appropriate labeling to stock items.
Sort and distribute miscellaneous items received to appropriate individuals or departments.
Prepare and pack case and pallet size shipments and all associated documentation as per written standard operating procedures.
Pick material work orders to be delivered to shop floor.
Stock all warehouse and KANBAN locations. Move materials as necessary to maintain neat, organized warehouse.
Perform inventory counts and cycle counts dictated by established periodic schedule.
Drive the company vehicle.
Other related duties as assigned in support of department/organizational duties and initiatives.
Operate, maintain, and troubleshoot process equipment utilized in the collagen business, and be able to make minor equipment adjustments as needed.
Responsible for performing precise measurements and using measurement equipment to accurately add chemicals to batches.
Responsible for the cross linking, cutting, packaging and boxing of the product in its finished goods form, which includes performing visual product and component inspections to identify and remove defects.
Pass and maintain gowning qualification to perform Gowning Requirement for ISO Class 5 Clean room operations or ISO Class 7 Clean room operations.
Responsible for accurately maintaining legible and accurate records, required logs, books, records, and other procedures to comply with regulatory requirements, Good Manufacturing Practices (GMP), Quality Systems Regulations, Standard Operating Procedures (SOP’s), and Health and Safety requirements.
Interface with QA/QC/Material departments during course of work to coordinate inspections and efficient flow of subassemblies and completed product.
Enter and record production activities in Oracle MRP systems to issue material and labor hours to specific work orders.
Follow applicable Standard Operating Procedures, Quality System Regulations and ISO 13485 requirements.
Responsible for reporting all discrepancies to the Supervisor or Group Leader.
Support department and plant Safety goals by continuously demonstrating safe behavior.
Maintain a clean and orderly work area
Ability to work flexible shifts, and flexible days within the week to meet batch milestone requirements
Perform other manufacturing activities as assigned by the department leadership
Primary responsibilities are to:
Work with internal and external parties to insure the proper items are received in a timely manner and documented appropriately.
Verifies all incoming materials and paperwork against purchase orders, notifies Buyer of any missing documentation, damages, shortages, and problem receipts.
Performs receipt transactions and material moves ensuring receipt and inventory accuracy in ORACLE.
Process all required receiving paperwork; affix all appropriate labeling to stock items.
Sort and distribute miscellaneous items received to appropriate individuals or departments.
Work with internal and external parties to insure the proper items are shipped in a timely manner and documented appropriately.