What are the responsibilities and job description for the Bulk Formulation Technician position at LanceSoft, Inc.?
12-hr NIGHT/rotating B-shift
7:00p-7:30a (Shift B, 2-2-3 rotation)
Position Summary:
Main Accountabilities:
Production
Quality
Safety
Other Duties
Studies, Experience, Skills and Qualifications:
Experience
Skills
Additional Information:
7:00p-7:30a (Shift B, 2-2-3 rotation)
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
Salary : $17 - $20
