Process Operator

3 weeks ago

Malvern, United States Medvacon Life Sciences Full time
Job DescriptionJob DescriptionShift: MON-THURS 1PM - 11:30PM
1. 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
  • 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

2. 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.

3. 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

4. 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.

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