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Manufacturing Operator - Blending & Granulation 1st Shift

ANI Pharmaceuticals, Inc.
Full-time
On-site
East Windsor, NJ
$16 - $35 USD yearly
Operations

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Role Summary

The Manufacturing Operator will work alongside other members of the production team to operate and maintain production equipment in accordance with Standard Operating Procedures. The Manufacturing Operator will also document all aspects of production and maintenance (batch records, room usage, cleaning and operation details) in corresponding logbooks as dictated by ANI Standard Operating Procedures and FDA GMP guidelines. The Manufacturing Operator should also have multiple years of experience with blending and granulation in a pharmaceutical production environment.

Responsibilities

  • Operation and set up of blending and granulation production equipment
  • Cleaning the production/ packaging rooms per Standard Operating Procedure
  • Cleaning, maintaining and operating production machinery as per Standard Operating Procedure
  • Following the instructions in the Batch Manufacturing Document while involved in production
  • Documenting production operation in the Batch Manufacturing Document
  • Documenting cleaning and operation details in the Equipment Log Book
  • Documenting room usage in the Room Log Book with cleaning and usage details
  • Complying to GMP requirements of FDA in all steps of activities

Qualifications

  • Must be 18 years or older
  • High School Diploma or equivalent education
  • Minimum 3 years of experience with blending and granulation and Pharmaceutical Formulation
  • Solid working knowledge of FDA GMP requirements
  • Must have the ability to perform repetitive work and meet ANI Pharmaceuticals standards
  • Must be able to read, comprehend and follow written and verbal instruction with accuracy
  • Must have the ability to read, comprehend and follow written and verbal procedures
  • Must have excellent accuracy/attention to detail
  • Must have good basic communication and interpersonal skills
  • Must be able to lift a minimum of 25 pounds
  • Other preferred qualifications include the ability to wear personal protective clothing/equipment and hearing protection where provided and must be able to work varying shifts

Skills

  • Attention to detail
  • Documentation and record-keeping
  • Equipment operation and maintenance
  • Compliance with FDA GMP
  • Communication and teamwork

Education

  • High School Diploma or equivalent

Additional Requirements

  • Must be able to lift a minimum of 25 pounds
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