Bulk Formulation Technician

Job Title: Bulk Formulation Technician (12hr Day)

Location:Durham, NC

Type: 6 Months Contract (Possibility of extension)

Pay Rate: Depends on experience

Job Description

This role is a generalized technician in the Formulation department and will require candidates to routinely lift heavy items. This is NOT a lab formulation role! Candidates need to be familiar with bulk mixing of raw materials.

12-hr Day/rotating shift

7:00am-7:30pm (2-2-3 rotation) Overtime likely available

Position Summary:

The Formulation Technician position is responsible for the operation of high speed equipment used in the production of BacT/ALERT bottles and/or preparation, staging, weighing of raw materials used for the formulation of the liquid reagents that fill the finished BacT/ALERT bottle in a cGMP compliant manner.

• The position may perform or assist in the setup, inspection, preventive maintenance, troubleshooting and cleaning of equipment used throughout the BacT/ALERT Manufacturing and Packaging processes.

• The position consists of the staging and preparation of raw materials used for Media Formulation

• Additionally, this individual will be responsible for completing production batches and corresponding documentation for the associated task.

Main Accountabilities:

• Production

• Manufacturing & Packaging:
Operate high speed manufacturing equipment, in some cases highly automated, using HMI/SCADA interfaces

• Filling: chemical weighing and reagent formulation

• Execute production activities per approved Manufacturing Directions while maintaining compliance with all job related SOPs

• Quality

• Ensure that all batch paperwork is completed in an accurate, thorough, and timely manner

• Perform and document all processes and procedures in a timely manner, while maintaining compliance with all company and regulatory agency regulations

• Provide assistance with the review and revision of Manufacturing Directions and SOPs necessary for the manufacture and packaging of product.

• Assist with manufacturing deviation analysis, CAPA actions and other process equipment related quality concerns

• Maintain all work areas in a well-organized, clean and tidy manner at all times in compliance with cGMP requirements

• Safety

• Comply with all safety policies and procedures at all times

• Appropriately use PPE (Personal Protection Equipment) as required to perform routine and non-routine duties.

• Other Duties

• Generate reports, charts and KPI's and interpret the data to identify problems, and proceed with proper decision making

• Assist with executing validation protocols associated with manufacturing/packaging equipment and procedures including revalidation as scheduled or required to maintain systems in a validated state

• Perform computer applications

• Perform other duties as assigned by Management

Studies, Experience, Skills and

Qualifications:



Experience

• Minimum of 0-1 years in a regulated production/operations environment

• Experience in weighing/Staging of raw materials used in large scale production preferred

Skills