Manufacturing Operator, Granulation & Blending (2nd Shift)

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 cGMP guidelines. The Manufacturing Operator should also have multiple years of experience with Granulation in a pharmaceutical production environment.

Responsibilities

• Operation of 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 cGMP requirements of FDA in all steps of activities

Qualifications

• 3-5 years of experience with Granulation and Pharmaceutical Formulation
• Solid working knowledge of FDA cGMP requirements
• Must be 18 years or older
• High School Diploma or equivalent education
• 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

• 3-5 years of experience with Granulation and Pharmaceutical Formulation
• Solid working knowledge of FDA cGMP requirements

Education

• High School Diploma or equivalent education

Additional Requirements

• Physical ability to lift at least 25 pounds
• Willingness to wear personal protective equipment and hearing protection as required