Description
Job Purpose
In accordance with the requirements of the Quality Management System (QMS), working with Engineering, Technical Services, Validation, Formulation, 503B Filling, Filling & Sterilization and Packaging (Operations teams), manage equipment and systems spare parts and format parts in an effective and compliant manner.
Essential Duties and Responsibilities
· Act as primary point of contact in the Warehouse Department for the management of equipment and systems spare parts and format parts.
· Prepare and maintain an accurate and current list of spare parts as required for each item of equipment / system within Nephron.
· Where appropriate and as recommended by the vendor assign spare parts an expiration date.
· Maintain a data sheet / specification and drawings as required for MRO parts.
· Based on NetSuite, assist with procedures to accept spare parts, receive inventory, remove spare parts from inventory and signal the reorder of spare parts.
· Based on RFSmart, prepare procedures to scan parts into and out of inventory including integration with NetSuite.
· Maintain the MRO spare parts storage area(s).
· Identify and assist with the qualification of secondary sources to provide like for like or equivalent critical spare parts.
· Support new equipment introductions (and associated MRO spare parts) with subject matter expertise.
· Support investigations with subject matter expertise.
· Ensure that the inventory control system documentation is maintained in accordance with the Quality Management System (QMS).
· Working with Warehouse Management, ensure the MRO Inventory team members are appropriately trained in accordance with their task requirements.
· Prepare and maintain metrics on inventory control system effectiveness / inventory entitlement.
Supplemental Functions
· Interact with all departments.
· Performs all other duties as assigned or apparent.
Requirements
Job Specifications and Qualifications
· Foundational mechanical knowledge associated with Nephron machinery and associated industry supply base.
Knowledge
- ✓Technically proficient in cGMP equipment.
- ✓Knowledge of FDA guidelines and regulations.
· Effective communication skills.
· Strong data analysis capabilities.
· Microsoft Excel knowledge – Intermediate level.
· NetSuite knowledge a plus.
Education / Experience
- ✓Bachelor’s degree with minimum of 2 – 3 years of previous experience in cGMP related environment.
Licensing and Certifications
- ✓Lean Six Sigma certification preferred.
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Working Conditions / Physical Requirements
- ✓Position requires bending (desk to floor), lifting (up to 40 lbs.), corrected vision (20/20), standing, sitting, typing, and walking.