Quality Assurance Associate
2 days ago
We are seeking a Quality Assurance Associate to support our Princeton, NJ office. The incumbent will be based in India and report to the Lead, Quality Operations/Batch Release - North America. This quality role will be responsible for supporting the batch release group in record reviewing and batch release of products to the US market.
Key Responsibilities:
- Responsible for QA oversight of 3PL distribution centers and inventory management.
- Batch record review and batch release of products involve the critical, independent review of Quality Control, manufacturing, packaging, and Quality Assurance records.
- Adhere to standards to ensure compliance with CGMP's and FDA expectations.
- Support and interface with customer service teams to provide customer requests for COAs and other documentation.
- Manage Quality secondary reconciliation updates in the DEA controlled substances import management system.
- Identifies trends and potential compliance gaps and drives quality improvement initiatives of the batch release team by tracking and trending Quality metrics.
Qualifications:
- An advanced degree in chemistry, organic chemistry, biochemistry, or a similar discipline is required.
- 2 to 4 years of experience working in a cGMP Quality role is required.
Skills & Attributes:
- Experience in Quality Assurance (QA) domain.
- Sound knowledge of CGMP and ICH regulations.
- Due diligence experience.
- Strong working knowledge of Microsoft Office (Excel, Word, PowerPoint, etc.) is required. Experience in ERP and QMS systems is a plus.
Our Work Culture:
We foster a culture of empathy and dynamism. People are at the core of our journey over the last few decades. They have been supported by an enabling environment that buoys individual ability while fostering teamwork and shared success. We believe that when people with diverse skills are bound together by a common purpose and value system, they can make magic.
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