Serve as support staff for the clean room laboratories and other departments. Maintain communication with the labs to ensure operations run smoothly according to the production schedule by planning and ordering ahead of time while following all relevant department policies, procedures, SOPs, and other requirements.

* Follow the Ceva documentation standards (Clear, Accurate, and Concurrent). Turn in all completed and verified paperwork to Team Lead. Print more records as needed with the correct version. Start new logs at the end of the month and collect all in-use records and logs at the end of the month.

* Perform Cycle counts as instructed by management

* Clean and disinfect non-clean room areas according to established protocols. Make spray bottles at the start of each day, following the guidelines and ensuring the bottles have updated labels containing the proper information

* Assist other areas as needed

Kitchen Tasks

* Maintain inventory of lab dishware, taking inventory and restocking as needed

* Clean all dirty dishware and equipment sent out from the labs; keep dishware and equipment separated by labs

* Wrap dishware and equipment in autoclave paper, label and place in the kitchen for autoclaving

* Load and unload the autoclave and complete associated paperwork, logs and records

* Maintain a clean and organized working station when wrapping dishware

* Cleaning and disinfection by making spray bottles, complete cleaning solution logs and be aware of hazardous wastes solutions, and ensure proper disposal of hazardous waste

* Supply inventory and stocking; ensure First In First Out (FIFO) practices are used, maintain the Kanban system and record and properly dispose of expired items

Dock Tasks

* Receive items on the Marek's dock from the warehouse following receiving protocols

* Ensure there is sufficient amount raw material thawed for laboratory use; thaw any needed frozen raw materials ensuring to follow thawing protocols (FIFO) and fill out records concurrently

* Maintain inventory in the coolers and freezers with daily item checks, ensuring items are labeled properly and not expired; dispose of expired items according to department protocols

* Ensure sufficient levels of EMEM and WFI water in the cooler

* Record receipts of items from outside vendors or the transfer of raw materials into the correction locations in JDE

* Ensure FIFO practices are used when following receiving protocols

* Ensure to clean equipment, rooms, and workstations throughout the workday following cleaning protocols and filling out logs or records concurrently

* Empty waste receptacles, dirty lab suits, biohazard bins throughout the Central area, following waste removal and biohazard bin protocols and stage on the dock at the end of the day to be taken to vendor

* Restock gowning shelves and check expiration dates to ensure supplies are not expired

* Fill out daily temperature logs for all central rooms: prep rooms, cooler, freezer, hallways, kitchens, nitro room, label room

* Operate forklift to bring over media pallets from Cooler to Marek's dock

* Order raw materials and dry stock from the vendor managed inventory system

* Ensure raw materials being received are QA released before they enter the production areas

Nitro Tasks

* Check temperatures and liquid levels in Liquid Nitrogen storage tanks and portable dewars and fill out necessary documentation

* Understand the production schedule in order to prepare the necessary documents for the day's final product fills

* Pull seed for the laboratories the day before the seed is needed; place seed back into tanks after inoculations, and fill out seed inventory records

* Visual inspection of every final product ampoule and place into cane in preparation of freezing

* Fill out all the proper logs and records for ampoule inventory

* Operate the programmable Gordiner freezers to freeze final product from the labs, filling out proper documentation

* Maintain a clean work are during and after the caning process, following cleaning protocols and fill out cleaning logs

Labeling Tasks

* Understand the production schedule in order to prepare proper amounts labels for ampoules

* Operate the label machine to place authorized and approved labels onto ampoules to be filled with final product from the labs

* Operate the dry, hot oven to clean and sterilize the outside of the ampoules

* Fill out all paperwork, logs and records that go with ampoules and equipment used to label the ampoules, concurrently

* Maintain a clean workstation, only work on one serial at a time and have station inspected in between serials

* Shape solutions out of complexity - Work to evolve immediate environment

* Client focus - Make sure needs and requests are treated equally and in a positive way

* Collaborate with empathy - Fully takes part in the working group to share information, listens to others and have a clear idea of the decisions taken

* Engage and develop - Open to share knowledge and to receive feedback from others

* Drive ambition and accountability - Ensure accuracy of work the use of KPI's and a responsible commitment

* Influence others - Show structure and confidence while speaking

* Must be able to become gown qualified

* Ensures compliance of all manufacturing processes in accordance with Regulatory Agencies (USDA, OSHA, Safety), Company Policies and Procedures

* Flexible to complete necessary tasks with last minute changes to the production plan

* Excellent communication skills both verbal and written

* Experience coordinating day-to-day activities

* Must be able to work in a team environment

* Ability to prioritize tasks for efficient completion of daily activities

* Ability to troubleshoot minor issues on the autoclaves

* Ability to work outside of set schedule, this may include weekends and holidays

Education - High school diploma or GED required

Work Experience - At least 1 year experience in a related field, laboratory manufacturing experience beneficial but not required

Other (consider certifications, specialized knowledge and/or training, etc.) - N/A

* Able to read, write legibly and communicate in English

* Standing: approximately 90% of the day is spent standing for extended periods of time

* Visual inspections

* Bending: approximately 60% of the shift has duties that require bending at the waist or knees

* Lifting up to 50 pounds

* Must be able to tolerate hot and cold working areas

* N/A

This job description is intended to convey information essential to understanding the scope of the job and general nature and level of work performed by job holders within this job. This job description is not intended to be an exhaustive list of qualifications, skills, duties and responsibilities or working conditions associated with the job. This job description is not an employment contract. Ceva reserves the right to modify job duties and/or job descriptions at any time to meet the needs of the business.