Aurobindo Pharma USA, Inc.
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QC Supervisor
role at
Aurobindo Pharma USA, Inc.
2 weeks ago Be among the first 25 applicants
Division Overview Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10‑year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump‑start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.
Job Overview The QC Supervisor focuses on the Quality Control Laboratory, offering project and task management along with technical leadership. The incumbent is tasked with ensuring QC testing is conducted in accordance with established procedures and guidelines. Moreover, they are entrusted with providing training, facilitating development, and offering necessary resources, information, and guidance. The QC Supervisor assumes responsibility for managing and coaching team members. Leveraging their technical expertise and knowledge of pharmaceutical testing, including critical issues related to test methods, laboratory instrumentation, and operational principles, as well as staying updated on current regulatory guidelines, they ensure the safe, efficient, and effective functioning of laboratory operations. This role plays a crucial part within the QC department, ensuring that team activities comply with relevant rules and regulations, such as current USP‑NF, cGMP, safety protocols, in‑house SOPs, and testing procedures.
Responsibilities
Leading a quality control team and managing associated lab focused on Aurolife Unit‑2.
Planning, organizing, and scheduling activities based on business needs.
Supervising 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.
Preparing for internal and external audits such as pre‑approval, cGMP, and post‑approval inspections by USFDA.
Other tasks as assigned.
Qualifications – Skills & Requirements
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 (e.g., aerodynamic particle size by cascade impactor, dose content uniformity, spray pattern, moisture content, assay and impurities, 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, and 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.
Desirable knowledge or experience with specialty products such as transdermals, topicals, inhalations.
Education & Experience
Minimum BS in a scientific field.
BS with Chemistry is preferable.
Minimum 5‑8 years experience in pharmaceuticals; at least 3‑5 years with generic pharmaceuticals.
Knowledge in Method Development & Method Validation; previous supervisory experience highly regarded.
Up‑to‑date knowledge in USP/ICH/FDA/cGLP/cGMP/Safety regulations.
Experience handling and testing control substances preferred.
Ability to learn quickly and train team members.
Technical, administrative, decision‑making, communication skills and ability to work under pressure.
Knowledge operating LIMS preferred.
Compensation Minimum: USD $75,000.00 / Yr.
Maximum: USD $95,000.00 / Yr.
Physical Requirements – LAB TECHNICIANS Must be able to bend at waist and knees, twist at trunk, lift up to 25 lbs, practice good personal hygiene, wear laboratory protective gowning and equipment (gowning, goggles, face shields, respirators, gloves). Position requires working in the laboratory as well as sitting.
Must practice good personal hygiene.
Must be able to lift up to 25 lbs.
Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and respirators are essential for the health and safety of employees.
Position requires working in the laboratory as well as sitting.
Physical Requirements – Schedule Lifting 8+ Hours – 0‑10 Pounds Sitting 1‑4 Hours Bending 1‑4 Hours Standing 4‑8 Hours Walking 1‑4 Hours
Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Aurobindo Pharma USA, Inc. by 2x.
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Durham, NC .
Durham, NC – Salary Range: USD $75,000.00‑$95,000.00 – Posted 1 day ago.
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QC Supervisor
role at
Aurobindo Pharma USA, Inc.
2 weeks ago Be among the first 25 applicants
Division Overview Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product development and manufacturing. Aurolife has a 10‑year history of extraordinary manufacturing practices in the solid oral dose arena. The support and expertise of our parent organization has given Aurolife a jump‑start in building a solid pharmaceutical portfolio very quickly. The Aurolife family consists of an experienced management team with expertise in manufacturing, R&D, Quality Assurance and Quality control and regulatory affairs. In addition to several formulations under manufacture, we have a robust pipeline of products. Aurolife's aim is to provide healthcare at economical prices to make this a healthier world to live in.
Job Overview The QC Supervisor focuses on the Quality Control Laboratory, offering project and task management along with technical leadership. The incumbent is tasked with ensuring QC testing is conducted in accordance with established procedures and guidelines. Moreover, they are entrusted with providing training, facilitating development, and offering necessary resources, information, and guidance. The QC Supervisor assumes responsibility for managing and coaching team members. Leveraging their technical expertise and knowledge of pharmaceutical testing, including critical issues related to test methods, laboratory instrumentation, and operational principles, as well as staying updated on current regulatory guidelines, they ensure the safe, efficient, and effective functioning of laboratory operations. This role plays a crucial part within the QC department, ensuring that team activities comply with relevant rules and regulations, such as current USP‑NF, cGMP, safety protocols, in‑house SOPs, and testing procedures.
Responsibilities
Leading a quality control team and managing associated lab focused on Aurolife Unit‑2.
Planning, organizing, and scheduling activities based on business needs.
Supervising 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.
Preparing for internal and external audits such as pre‑approval, cGMP, and post‑approval inspections by USFDA.
Other tasks as assigned.
Qualifications – Skills & Requirements
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 (e.g., aerodynamic particle size by cascade impactor, dose content uniformity, spray pattern, moisture content, assay and impurities, 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, and 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.
Desirable knowledge or experience with specialty products such as transdermals, topicals, inhalations.
Education & Experience
Minimum BS in a scientific field.
BS with Chemistry is preferable.
Minimum 5‑8 years experience in pharmaceuticals; at least 3‑5 years with generic pharmaceuticals.
Knowledge in Method Development & Method Validation; previous supervisory experience highly regarded.
Up‑to‑date knowledge in USP/ICH/FDA/cGLP/cGMP/Safety regulations.
Experience handling and testing control substances preferred.
Ability to learn quickly and train team members.
Technical, administrative, decision‑making, communication skills and ability to work under pressure.
Knowledge operating LIMS preferred.
Compensation Minimum: USD $75,000.00 / Yr.
Maximum: USD $95,000.00 / Yr.
Physical Requirements – LAB TECHNICIANS Must be able to bend at waist and knees, twist at trunk, lift up to 25 lbs, practice good personal hygiene, wear laboratory protective gowning and equipment (gowning, goggles, face shields, respirators, gloves). Position requires working in the laboratory as well as sitting.
Must practice good personal hygiene.
Must be able to lift up to 25 lbs.
Must be able to wear laboratory protective gowning and equipment, including but not limited to gowning, goggles, face shields, respirators, and protective gloves. PPE and respirators are essential for the health and safety of employees.
Position requires working in the laboratory as well as sitting.
Physical Requirements – Schedule Lifting 8+ Hours – 0‑10 Pounds Sitting 1‑4 Hours Bending 1‑4 Hours Standing 4‑8 Hours Walking 1‑4 Hours
Blood/Fluid Exposure Risk Category III: Tasks involve no exposure to blood, body fluids or tissues. Category I tasks are not a condition of employment.
Seniority level Mid‑Senior level
Employment type Full‑time
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
Referrals increase your chances of interviewing at Aurobindo Pharma USA, Inc. by 2x.
Get notified about new Quality Control Supervisor jobs in
Durham, NC .
Durham, NC – Salary Range: USD $75,000.00‑$95,000.00 – Posted 1 day ago.
#J-18808-Ljbffr