About the position
Aurolife, a division of Aurobindo Pharma USA, Inc., is seeking a QC Technical Reviewer to join our team in Durham, NC. Founded in 2008, Aurolife has established a strong reputation in the generic pharmaceutical industry, particularly in the development and manufacturing of solid oral dosage forms. Our commitment to excellence is supported by a robust management team with extensive experience in manufacturing, research and development, quality assurance, and regulatory affairs. We aim to provide affordable healthcare solutions to improve global health outcomes. The QC Technical Reviewer will play a critical role in ensuring the quality and compliance of our pharmaceutical products. This position is responsible for the technical review of raw data, qualification protocols, Certificates of Analysis, and other technical documents necessary for the release of raw materials, finished products, and stability monitoring. The reviewer will support laboratory investigations and write technical reports related to method transfers and verifications for components, raw materials, and finished products. Compliance with standard operating procedures and regulatory requirements is paramount, and the reviewer will also provide training to department employees based on deviations and laboratory investigations. In this role, the QC Technical Reviewer will collaborate with various departments, including technical services, material management, manufacturing, and packaging, to identify the scope of investigations and determine root causes. The position requires a proactive approach to implementing corrective actions, tracking their effectiveness, and ensuring adherence to cGMP standards. The reviewer will also oversee investigations to guarantee clarity, completeness, and rigorous technical content, fostering a culture of quality and continuous improvement within the organization.
Responsibilities
- Technical review of raw data for the QC group
- Technical review of method transfer/verification protocols
- Technical writing of specification documents, standard test procedures, general test procedures, SOPs, qualification protocols
- Review, manage, and monitor stability trend tables
- Support investigations that arise in the QC testing of raw materials/finished products as needed
- Work with all parties as applicable, technical services, material management, manufacturing, packaging, and the laboratory to identify the breadth and scope of the investigation to determine the appropriate root cause
- Support the implementation of corrective actions, complete the trending analysis and determine product disposition as applicable
- Foster a collaborative relationship with manufacturing and laboratory personnel focused on high quality systematic investigations, meaningful corrective actions, and reducing the deviation generation rate
- Provide support to determine appropriate corrective actions to prevent reoccurrence of the deviation
- Track effective measure of each implemented corrective action and take appropriate action if and when required
- Provide oversight and final review of investigations to ensure adherence to cGMP, rigorous technical content, investigation clarity and completeness
Requirements
- B.S/MS degree in engineering/Chemistry/Scientific field
- Minimum 3 years experience in an analytical role, technical review role, or quality assurance role with an emphasis on raw data review within the pharmaceutical industry
- Familiarity with Empower 3 data collection system
- Working knowledge of cGMP's and regulatory requirements as they apply to pharmaceutical testing
- Familiarity with compendial methods (USP/NF, EP, JP, BP etc.)
- Experience in investigation/deviation management
- Technical writing skill with experience related to both laboratory and manufacturing investigations
