ANI Pharmaceuticals, Inc.
Quality Assurance Operations In-Process Reviewer
East Windsor, NJ - Full Time
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
This position is responsible for providing support to the Manufacturing and Packaging Operations to ensure relevant procedures are followed and meet GMP requirements.
Responsibilities:
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
This position is responsible for providing support to the Manufacturing and Packaging Operations to ensure relevant procedures are followed and meet GMP requirements.
Responsibilities:
- Perform packaging line inspections/audits and provide assurance that packaging operations are compliant with applicable SOPs and cGMPs
- Perform finished product attribute sample inspection and evaluation of finished products physical characteristics prior to packaging
- Perform annual retain sample inspections and control finished product and raw material retain samples stored in the reserve sample room
- Monitor GMP areas for compliance with general GMP requirements such as proper gowning and cleanliness, per CFR21 Subpart A General Provisions to assure they reflect current practices and meet industry standards and cGMP requirements
- Perform in-process checks while packaging and ensure packaging meets the batch record specified parameters
- Review and ensure compliance of online batch documentation as per the batch record instructions
- Perform other duties as assigned or requested
- Excellent oral and written communication skills
- Willingness to learn
- Ability to work in a dynamic environment
- Interpersonal skills
- Experience in a GMP environment, or previous experience in Quality Assurance is not required but appreciated
- Bachelors degree is required.
- Ability to coordinate multiple tasks in a fast-paced environment
- Ability to read and follow Standard Operating Procedures
- Attention to detail
- Must be able to work within a team environment
- Must be able to work possible shift changes
