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Process Operator

4 months ago

Malvern, United States A.P.R., Inc. (AlphaProTemps) Full time
Job DescriptionJob Description

Position: Process Operator

Location: Malvern PA 19355

ONSITE - TEMP TO HIRE - SHIFT - MON-THURS 1PM - 11:30PM

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

Position Requirements:

  • Prior manufacturing experience and work in a regulated environment preferred
  • Ability to work weekday and weekend OT a plus.
  • 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.
  • 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.
  • 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)
  • Stops and asks questions or suggests improvements when something is unclear.

 

 

 

Education or Equivalent:

· High School Diploma or GED

Company DescriptionAlphaProTemps is specialized in providing "best-in-class" professional staff augmentation services. These recruiting directives include temporary labor, contract sourcing, professional & technical niches, vendor-on-site, and managed service programs.Company DescriptionAlphaProTemps is specialized in providing "best-in-class" professional staff augmentation services. These recruiting directives include temporary labor, contract sourcing, professional & technical niches, vendor-on-site, and managed service programs.