Location: 333 Phoenixville Pike, Malvern, PA 19355, United States
Duration: 06 MONTHS.
Timings: MON-THURS - 1:00PM - 11:30PM
WILL TRAIN ON FIRST SHIFT THE FIRST 2 MONTHS. FLEXIBLE TO WORK FRIDAY OR WEEKENDS IF THERE IS BUSINESS NEEDS.
100% Onsite Role - TEMP TO HIRE
Description
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 Catalent 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
Seniority level
Entry level
Employment type
Full-time
Job function
Management and Manufacturing
Industries
Staffing and Recruiting
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