Aurobindo Pharma USA, Inc. · 5 months ago
QC Technical Reviewer
Durham, North Carolina
Full-time
Onsite
Mid Level
3+ years expAurobindo Pharma USA, Inc. is a leading company in generic pharmaceutical product development and manufacturing. The QC Technical Reviewer is responsible for the technical review of raw data and various technical documents to ensure compliance with regulatory requirements and standard operating procedures. This role also involves supporting laboratory investigations and providing training to department employees as needed.
BiotechnologyPharmaceutical
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
This role will foster a collaborative relationship with manufacturing and laboratory personnel, focusing on high-quality, systematic investigations, meaningful corrective actions, and reducing the rate of deviation generation. Provide support to determine appropriate corrective actions to prevent the recurrence of the deviation
Track the effective measure of each implemented corrective action and take appropriate action if and when required
Provides oversight and final review of investigations to ensure adherence to cGMP, rigorous technical content, investigation clarity, and completeness
Qualification
Required
B.S/MS degree in engineering/Chemistry/Scientific field required
Minimum 3 years of 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 cGMPs 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 skills with experience related to both laboratory and manufacturing investigations
Company
Aurobindo Pharma USA, Inc.
Aurobindo Pharma is a pharmaceuticals company offering generic pharmaceuticals.
501-1000 employees
H1B Sponsorship
Aurobindo Pharma USA, Inc. has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (12)
2024 (4)
2023 (4)
2022 (10)
2021 (9)
2020 (10)
Funding
Current Stage
Late StageLeadership Team
Swami Sambamurty Iyer
Chief Executive Officer
Recent News
2025-06-28
Business Standard India
2024-11-25
2024-11-24
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