Title: Manufacturing Operations Specialist
Location: On-Site - Morris Plains, NJ 07950
Duration: 12 Months
Shift Schedule:
Rotational shift (workdays to be determined)

Description:
The Manufacturing Operations Specialist is responsible for the Dispensary / ISO8 area tasks including kitting and material flow, inventory management and other duties required to support the core functions.

Key Responsibilities:
Adhere to all area governing SOPs, WPs, and batch records with a focus on Right First-Time performance. Ensure accurate SAP/MES inventories are maintained for all components.
Ensure Manufacturing Support areas are maintained in an audit ready state.
Ensure equipment cleaning and maintenance is performed per governing SOP requirements.
Escalate any observed compliance or safety issues and support reconciliation of event.
Proficient in various operating systems, including but not limited to LIMS, SAP, MES etc.
Support monthly and annual cycle count and support all site/team projects and initiatives.
Coordination of receiving, storage and processing of materials.
Ensure inventory accuracy of GMP and non-GMP LN2 storage locations.

Dispensary / ISO8 Activities:
Ensure accurate SAP/MES inventories are maintained for all components.
Ensure proper status segregation and storage of all conditioned and ambient materials.
Ensure Kanban system is accurate, and materials are consumed per FEFO/FIFO.
Ensure kitting/staging of initial kits are complete for each shift and timely response to kitting requests for production.
Monitor staged kits for expired materials and to ensure utilization prior to expiry.
Ensure all gowning materials in the ISO8 staging area are maintained to adequate levels.
Ensure dispensary area has ample supply of non-BOM items.
Alternate shifts, weekends and overtime will be required as needed.

Role Requirements:
1-3 years of related experience in cGMP/FDA regulated industry; warehouse experience preferred. High School degree required. Bachelor's degree preferred.
Strong interpersonal, written and communication skills along with problem solving and follow-up skills are required.
Must be well organized, flexible and work with minimal supervision.
Ability to lift up to 50 lbs., assisted.
Requires handling of chemicals such as corrosives, solvents & bio-hazardous material.