Job: Production Technician

Job Scope:

Successfully work within the Classified Areas and the Packaging and Labeling Rooms within a GMP aseptic fill manufacturing facility to manufacture sterile products. Full-time position with a 4-day work week within a clean/temperature controlled environment throughout the entire facility. First shift only. Holiday pay upon hire. The position is located in Grand Island, Nebraska.

Responsibilities:

• Clean equipment after production run and prep equipment for next run
• Able to follow Standard Operating Procedures (SOP’s) without alteration
• Process components of production including stoppers, crimp seals, boxing, labeling, and palletizing
• Clean processing rooms after production run
• Machine set-up and teardown
• Aseptically work within the Classified Area
• Successful gowning requirements
• Troubleshoot machines and equipment
• Transfer of equipment in and out of Sterilizer
• Assist with Media Fills and Validations
• Other duties as assigned

Job: Compounding Technician

Job Scope:

Perform compounding of raw material components for production lines to achieve a homogeneous in-process material within a GMP aseptic fill manufacturing facility that is suitable for further processing. Must be able to lift 30-15 lbs repetitively. Full-time position with a 4-day work week within a clean/temperature controlled environment throughout the entire facility. First shift only. Holiday pay upon hire. The position is located in Grand Island, Nebraska.

Responsibilities:

• Rinse 4,000 gallon mixing tanks prior to use
• Pre-Filter set up
• Weigh and stage raw materials
• Follow Batch Formulas to complete compounding of product
• Clean Compounding rooms and Staging Warehouse
• Other duties as assigned

Job: Maintenance Technician

Job Scope:

Responsible for ensuring building and equipment used in manufacturing, processing, packing, and holding of products or components within a GMP aseptic fill manufacturing plant are maintained in a good state of repair. Successfully work within the Classified Areas and the Packaging and labeling Rooms and run production line within a GMP aseptic fill manufacturing facility to manufacture sterile products. Full-time position with a 4-day work week after orientation within a clean/temperature controlled environment throughout the entire facility. Holiday pay upon hire. The position is located in Grand Island, Nebraska.

Responsibilities:

• Maintain and perform scheduled preventative maintenance for building and equipment with documentation of activity
• Accompany outside repair service for jobs performed
• Submit orders for spare parts to the Vice President of Facilities & Equipment for approval
• Maintain organization and cleanliness of the maintenance office and working area as well as good working condition of all tools
• Work in production to attain knowledge of the manufacturing process
• Cleaning and relat4ed activities such as snow or debris removal from sidewalks and landscaped areas of the building grounds
• Capable of safely operating hand-operated tools, small power equipment, vehicles, and any other job-related equipment
• Follow instructions regarding the use of chemicals and supplies
• Attend meetings and training as required
• 24-hour availability of service for maintenance emergencies
• Janitorial and other duties as assigned
• Other duties as assigned

Job: Project Scientist

Job Scope:

Coordinate efforts associated with the management function for existing and new projects and activities. Assist in the preparation of product development and regulatory documents and application for federal and state submission. Facilitate obtaining, updating, evaluating, compiling, and maintaining information and documents from internal and external sources for regulatory submission, registration, and license renewals. Research and interpret current regulations and guidance to facilitate their implementation. Maintain contemporaneous notes and catalog appropriately. Full-time position with a 5-day work week within a clean/temperature controlled environment throughout the entire facility. Paid uniforms. First shift only. Holiday pay upon hire. The position is located in Grand Island, Nebraska.

Responsibilities:

• Coordinate efforts associated with the management function for existing and new projects and activities
• Facilitate the update of the Veterinary Master File and Site Master File. Manage letters of authorizations/references
• Federal and state license renewals
• CVM/CVM Drug Listing
• Coordinate and communicate with customer for CMC related transfer and development activities
• Interact with customer/drug sponsor for submission documentation support
• Maintain, update, and communicate work progress and timeline impacts
• Support internal and external qualifications and validation studies
• Facilitate in process assessment and implementation. Facilitate gap analysis, identification, and mitigation
• Provide customer APR and batch record. Coordinate customer change requests and notifications externally and internally. Manage and assess supplier change notifications
• Facilitate in component and material sourcing, negotiation and supplier qualification
• Cross trained on Quality System III responsibilities
• Other duties as assigned