Job Description
The Process Operator micronize\mills client provided material including both active pharmaceutical ingredients and excipients as per company procedures and policies, client instructions and cGMP guidelines. Consistently models company 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 company
- 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 and Experience:
- High School Diploma or GED
- 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.
?Pay Rate: $23/hr
Job Tags
Contract work, Shift work, Weekend work, Weekday work,