What are the responsibilities and job description for the Chemical Operator/ GMP Manufacturing Associate position at Kunsh Technologies?
Responsibilitites:
o Perform entry-level micronization and milling of both hazardous and non-hazardous pharmaceutical actives and excipients.
o Set up, operate equipment, and monitor production processes.
o Report production on batch records following good documentation procedures (GDPs).
o Work in a regulated environment with adherence to standard operating procedures and policies.
o Adhere to cGMP standards.
o Identify and communicate non-routine events, deviations, and GMP deficiencies to supervisor promptly.
o Clean the entire processing area and processing equipment.
o Produce thorough, clear, and consistent documentation in compliance with Quality Standards (Attributable, Legible, Contemporaneous, Original, and Accurate).
o Demonstrate willingness to accept change, learn, and work with new processes.
o Stop and ask questions or suggest improvements when something is unclear.
o Participate in shift change meetings, site/team meetings, sending/receiving emails, offering suggestions for improvements, and participating in projects.
o This is a site-based position.
o Strive to achieve First Time Right (FTR) as a key performance indicator (KPI) in order to meet our yearly targets.
o Remain current with Compliance Wire and other site training.
o Perform all other duties assigned by management
Measures of Performance:
- Adherence to safety and quality procedures
- Product quality, throughput and final yields
- Excellent attendance, punctuality, and dependability
- Operators’ work ethic and general attitude as it pertains to the daily operations of the facility
Education or Equivalent:
High School Diploma or GED
Experience:
- Must be dependable, ready/eager to learn and able to meet the physical requirements of the job.
- Prior manufacturing experience and work in a regulated environment preferred.
- Ability to work weekday and weekend OT a plus.
Knowledge/Skills Requirements:
Technical Skills/Knowledge
- Communication Skills Oral and Written
- Basic Math Skills, interpretation
- Potential limited exposure to heath & physically hazardous chemicals.
- Personal protective equipment, including gloves, a respirator hood, safety glasses, safety shoes and other Personal Protective Equipment is provided and is required to be worn in designated areas.
- Prior Production Experience preferred
Physical Requirements/Work Environment:
- Physical strength, stamina and dexterity while wearing fully enclosed air suite
- Employees be able to lift or move items up to 44 lbs. (20kg) individually, or with a two-person lift between 45 lbs and 76 lbs. (35kg). 77 lbs and over with a lift assistance device.
- Ability to work safely with high potency active pharmaceutical ingredients (HPAPI) as well as novel compounds of unknown potency and toxicity
- Ability to perform moderate physical labor including: lifting, climbing, bending, crouching, reaching and twisting
- Ability to stand or walk for up to 8 hours per day.
- Ability to climb steps/ladders and occasionally work from elevated platforms.
- Ability to wear a respirator hood and pass the required respiratory medical exam.
- Ability to work in loud environments and wear various types of hearing protection
- Ability to work with chemicals, health/physical hazardous material safely and in compliance with the site safety program.
Job Types: Full-time, Temp-to-hire
Pay: $22.81 - $23.98 per hour
Work Location: In person
Salary : $23 - $24