QA Reviewer

Job DescriptionJob DescriptionAbout 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 is an opportunity to join the QA team at the East Windsor, NJ facility. The position is Monday through Friday from 8:00 a.m. to 5:00 p.m. This position will follow and ensure compliance with current GMP requirements and all SOPs.

Responsibilities:

• Review batch records online to ensure batch entries are made correctly.
• Oversee that all materials are weighed correctly before initiation of the manufacturing process.
• Review all stages of the batch record and ensure manufacturing and packaging are carried out correctly. Identify if any out-of-limit results are recorded.
• Monitor production areas for compliance with SOPs, cGMP, and safety requirements.
• Review electronic data and find if there are any non-compliances with the batch process.
• Follow and comply with SOP and batch record requirements. Ensure batches are manufactured according to the SOP and batch record requirements.
• Identify and resolve routine errors that occur during manufacturing and packaging. Prevent possible deviations that affect production in real-time.
• Ensure validation batches are manufactured as per the protocol requirements.
• Perform in-process checks as necessary while manufacturing and packaging of intermediate and finished product batches.

Skills:

• Understand the quality and safety requirements according to FDA regulations and the SOPs.
• The ability to understand and follow all defined SOPs.
• Communicate work-related issues and details effectively with the supervisor and team members.

Requirements:

• Hold a degree in science or life sciences with a bachelor’s degree preferred.
• 5-7 years of experience working in the pharmaceutical or related industry.
• Knowledgeable about all FDA regulations and the ability to adhere to SOPs.

Please note that ANI does not accept search agency or third-party emails, calls, or solicitations.  
 

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