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Bulk Formulation Technician
Ref No.: 24-122921
Location: Durham, North Carolina
Start Date: 07/23/2024

Production Worker/Bulk Formulation Technician
Location: 100 Rodolphe Street Durham NC 27712
Duration: 7+ Month temp-to- Hire the right resource!
Shift hours: 7:00a-7:30pm / Day Shift/C Team 12 hr shift 2-2-3 Schedule
Pay Rate: $17/hr

Job Description

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 tasks
· Shift hours: 7:00a-7:30pm / Day Shift/C Team 12 hr shift 2-2-3 Schedule

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
· Certification in Bioworks Program preferred

· For Formulation

· Background in Bulking and/or compounding in food, supplement, cosmetic, medical device, or pharmaceutical chemical formulation is desired.
· Familiarity with measurement scales, mixing, blending, chemical mills and other formulation manufacturing equipment strongly desired.
· Knowledge of and experience in following OSHA regulations (LOTO, electrical safety, etc.) preferred.
· Knowledge of FDA and/or GMP regulations preferred.
· Mechanical background preferred.
· Ability to rapidly learn new procedures and reduce them to practice.
· Must be able to learn, comprehend and demonstrate competency in operating new equipment within a 75-day period of working with a trainer.

Additional Information:
· Performs all job functions and responsibilities in a safe and responsible manner.
· Ability to regularly climb stairs to perform work.
· Ability to routinely lift 50-75 lbs.
· Heavy lifting Involved
· Ability to stand for extended periods of time on shifts that could range from 8-12 hours.
· Ability to operate motorized pallet jacks.
· May be exposed to and require the handling of chemicals, antibiotics and/or hazardous materials.
· May be exposed to strong odors incurred during media production or other operations.
· Lab work is performed wearing various types of PPE which include but is not limited to a hairnet, beard cover, safety glasses, safety shoes, hearing protection, gloves, PAPRs, face mask and lab coats. Make-up and jewelry are prohibited in certain areas of Manufacturing.
· Ability to maintain reliable and punctual attendance
· Ability to work overtime as required to support a 24/7 production operation