Process Operator

Job Description

Job Description:

The Process Operator micronize\mills client provided material including both active pharmaceutical
ingredients and excipients as per Company Micron Technologies procedures and policies, client instructions
and cGMP guidelines.

II. Essential Functions:
• Micronization and milling of both hazardous and non-hazardous pharmaceutical actives and excipients.
• Set up, operate equipment, and monitor production processes and report production on batch records in accordance with good documentation procedures (GDPs)
• Review documentation (batch records, SOPs, Logbooks) for completeness, clarity, accuracy and submit edits to documents for revision as required.
• Ability to work in a regulated environment with adherence to standard operating procedures
• Capable of reading and following defined SOPs and policies and executes tasks accordingly.
• Work in accordance with cGMP. Identify and communicate non-routine events, deviations and GMP deficiencies to supervisor in a timely manner.
• Cleaning of the entire processing area and processing equipment.
• Produce thorough, clear & consistence documentation in compliance with Quality Standards (Attributable, Legible, Contemporaneous, Original and Accurate)
• Willingness to accept change, learn, and work with new processes.
• Stops and asks questions or suggests improvements when something is unclear.
• Participate in shift change meetings, site/team meetings, sending/receiving emails, offering suggestions for improvements, and participating in projects.
• Strives for First Time Right
• Remains current with CompliaceWire and other site training
• Carry out all duties in line with the procedures and policies set forth by Company Micron
• This is a site-based position.

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

III. Position Requirements:

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
• Organizational Skills
• Detail Orientation
• Communication Skills Oral and Written
• Basic Math Skills, interpretation
• Ability to Multi-task and prioritize
• Willingness to accept change, learn, and work with new processes.
• 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 wear a respirator hood and pass the required