What are the responsibilities and job description for the Manufacturing Operator - (Coating) position at ANI Pharmaceuticals?
About Us
Welcome to ANI Pharmaceuticals, where we are dedicated to improving and enhancing patients' lives through the manufacturing and distribution of high-quality pharmaceutical products. With a diverse portfolio of generic and branded pharmaceuticals, ANI is a trusted partner for healthcare providers, pharmacists, and patients alike. We understand the importance of accessibility, and our products are available across a wide range of therapeutic areas, contributing to the well-being of communities globally.
At ANI Pharmaceuticals, there are opportunities to contribute to our purpose every day. We value authenticity, knowledge, and hard work, we strive to celebrate our employees in a positive environment. Our culture empowers everyone to be successful and apply our full potential.
About the Role
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 Coating in a pharmaceutical production environment.
Responsibilities
- Operation and set up of coating 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
Requirements:
- Must be 18 years or older
- High School Diploma or equivalent education
- Minimum 3 years of experience with Coating 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
