Manufacturing Specialist

Manufacturing Operations Specialist

Location: Morris Plains, NJ

Start: ASAP

Project Length: 12 months, possible to extend

Pay: $24.91 - $27.53 per hour (depending on experience)

IMPORTANT NOTE: The hours will be 10:00am - 6:30pm. Days will either be Tuesday - Saturday or Sunday - Thursday. The contractor will not pick their days. Must be flexible for either shift as the team assigns it based on need.

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.

Shift Schedule:

Rotational shift

Days: Tuesday - Saturday or Sunday - Thursday