Previous Job
Previous
Bulk Formulation Technician
Ref No.: 24-125429
Location: Durham, North Carolina
Position Type:Contract
Start Date: 07/26/2024
Title: Bulk Formulation Technician
Location: Durham, NC, 27712
Duration: 6+ months with possibility of extension
Shift hours: 7:00a-7:30pm / Day Shift 12 hr shift 2-2-3 Schedule
Pay Rate: $17/hr

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
 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
  • Help 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 always in compliance with cGMP requirements
  • Safety
  • Always comply with all safety policies and procedures
  • 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 Bio works 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 odours 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 jewellery 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.