What are the responsibilities and job description for the Machine Operator position at KESIN PHARMA CORPORATION?
About Kesin Pharma
Kesin Pharma is a rapidly growing pharmaceutical company specializing in the repackaging and distribution of prescription and OTC products. We are committed to operational excellence, regulatory compliance, and providing reliable, high-quality products to our partners.
Position Overview:
Ensure individual compliance with FDA regulations, cGMPs, and all other applicable requirements, applicable department programs to include training, documentation, standard operating procedures, and Kesin Pharma Corporation policies.
This is a 4-day, 10 hour shift from 6:30am to 7:00pm, Monday through Thursday.
Key Responsibilities:
- Ensure compliance with all current Good Manufacturing Practices (cGMPs), SOPs and facility safety standards as related to the equipment, work area, and personnel.
- Know all procedures and perform paperwork documentation for all filling operations (unit dose, ointments products).
- Document pertinent information onto documents (Batch Records, Forms, Logs) neatly and accurately, following Good Documentation Practices (GDP). Know the function and purpose of batch record paperwork.
- Able to setup, operate, teardown, and clean the following efficiently and effectively, following all safety procedures (thermoform packaging machines, ointment packaging machines, serialization equipment (Antares)).
- Monitor the quality of the container being packaged and take corrective actions maintain the quality of the product.
- Communicate issues and concerns with equipment and personnel to Management.
- Maintain an orderly and clean work area.
- Attend training sessions to increase knowledge in machine operation, safety, cGMPs, and procedures.
- Interact with QA to assure all quality specifications are being met.
- Perform other duties as assigned my Management.
Qualifications:
- A high school diploma or equivalent and a demonstrated mechanical aptitude is required.
- One year machine operator experience or a combination of education, training, and experience.
- Must be able to read/write English fluently and neatly.
- Must be able to lift 60 pounds effectively and stand for long periods of time.
This job description does not state or imply that the above are the only duties and responsibilities assigned to this role. There are other duties and responsibilities that are considered incidental or secondary to the overall purpose of this position. Employees holding this position will be required to perform any other job-related duties as requested by management.
Location: Oldsmar, FL. The facility is in two neighboring buildings, and routine movement between buildings is required.
Department: Production
Reports To: Production Manager
Job Type: Full-time
Benefits:
- 401(k)
- Dental insurance
- Health insurance
- Paid time off
- Vision insurance
Work Location: In person