Aurobindo Pharma USA, Inc. · 1 day ago
QC Supervisor
Durham, NC
Full-time
Onsite
Senior Level, Lead/Staff
$75K/yr - $95K/yr
8+ years expAurobindo Pharma USA, Inc. is focused on providing economical healthcare through its pharmaceutical products. The QC Supervisor will lead the Quality Control Laboratory, ensuring compliance with established procedures and guidelines while managing a team and overseeing laboratory operations.
BiotechnologyPharmaceutical
Responsibilities
Leading a quality control team and managing associated lab focused on Aurolife Unit-2
Planning, organizing, and scheduling activities based on business needs
Supervise Daily Operations: Oversee the quality control department’s day-to-day operations
Responsible for Data Integrity compliance and laboratory GLP/cGMP/GxP compliance
Ensuring the accuracy of analytical measurements and compliance with cGMP, US FDA, and other regulatory and corporate requirements
Conducting troubleshooting and investigations using critical thinking skills and creativity in problem-solving
Overseeing analytical method transfers and method verifications
Preparing and reviewing Test Procedures, SOPs, Protocols, and Reports
Reviewing analytical data generated in the laboratory for accuracy and adherence to documentation requirements. Compiling data and trend summaries for regulatory submission
Communicating and coordinating activities with other departments such as manufacturing, Quality Assurance, and R&D
Providing status updates to management and promptly communicating any observed technical or scheduling problems
Taking the lead on special tasks assigned by management is expected
Preparing for internal and external audits such as preapproval, cGMP, and post-approval inspections by USFDA are significant responsibilities
Other tasks as assigned
Qualification
Required
Minimum of 8 to 10 years of experience in the pharmaceutical industry, preferably with 3 to 5 years of experience in drug device combination product pharmaceuticals
Experience in release and stability testing of metered dose inhalers, Transdermal and Topicals, including chromatographic and product performance testing. Relevant experience should include tests such as aerodynamic particle size by cascade impactor, dose content uniformity, spray pattern, moisture content, assay and impurities, and excipient content. Transdermal physical and chemical testing
Knowledge and experience in method transfer and validation, with prior supervisory roles being advantageous
Familiarity with pharmaceutical regulatory standards, including USP/ICH/FDA 21 CFR 210/211, CFR 11 & CFR 820/ISO 13485/cGMP/safety etc
Experience in leading a team and managing a lab in a fast-paced environment
Expert organizational and project management capabilities. Strong oral and written communication skills
Minimum BS with Scientific field
BS with Chemistry is one of the subjects would be preferable
Minimum 5-8 years experience in pharmaceuticals. Should have at least 3-5 experience with generic pharmaceuticals. More QC experience in generic pharmaceuticals industries would be an added advantage
Ability to learn quickly & Train team members
Technical, Administrative, Decision making, Communication skills and Ability to work under pressure
Preferred
Desirable knowledge or experience with specialty products like Transdermals, Topicals, Inhalations
Knowledge in Method Development & Method Validation would be preferable and previous supervisory experience would be added advantage
Up-to-date knowledge in USP/ICH/FDA /cGLP/cGMP/Safety regulations would be added advantage
Experience handling and testing Control Substances would be preferable
Knowledge in operating the LIMS would be preferable
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
Company data provided by crunchbase