What are the responsibilities and job description for the Process Operator position at Ampcus, Inc?
Job Description:
The Process Operator micronize\mills client provided material including both active pharmaceutical
ingredients and excipients as per Client Micron Technologies procedures and policies, client instructions
and cGMP guidelines. Consistently models Client values and leadership behaviors in all interactions.
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 Client 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
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.
Ampcus is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identify, national origin, age, protected veterans or individuals with disabilities.