Chemist C

Aurobindo Pharma USA, Inc.; Durham, Northern (NC, KY); Hybrid; USD 80,000 - 90,000; Full time

Job summary

Aurolife is seeking a Chemist C to perform analysis, review, and investigations while maintaining GLP in the laboratory. The role emphasizes test execution on materials across the product lifecycle, with emphasis on accuracy and regulatory compliance.

Candidates should have a BS in a scientific field, 4–6 years pharma experience, and 3–5 years in analytical testing or QC in generics. Strong knowledge of USP/ICH/FDA guidelines is required.

Qualifications

• Minimum BS with scientific field required.
• Chemistry background preferred for the role.
• 4–6 years in pharma with 3–5 years in analytical testing.
• QC experience in generics advantageous. Knowledge of GMP/GLP and USP/ICH/FDA.

Responsibilities

• Perform sampling, physical and chemical tests on raw materials, APIs, in-process and finished products using HPLC, GC, UV-Vis, IR and other QC instruments.
• Plan and inventory test reagents and ensure supplies are adequate for timely testing.
• Execute testing to meet established timelines with supervision as needed.
• Record data accurately and maintain clear documentation.
• Prepare and review test procedures, SOPs, and protocols.
• Calibrate laboratory instruments with supervision.
• Troubleshoot investigations under supervisor direction.
• Ensure compliance with regulatory requirements (cGMP, cGLP, housekeeping and safety).
• Review analytical documents and maintain GLP in the lab.
• Handle QAMS document management and other duties as assigned.

Education

Minimum BS with Scientific field

BS with Chemistry is one of the subjects would be preferable

Minimum 4-6 years experience in pharmaceuticals

3-5 year experience in Analytical testing

3 years QC experience in Generic Pharmaceutical industries would be preferable

Job description

Division Overview

Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical prouct 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 managementteam with expertise in manufacturing, R&D, Quality Assurance and Qualitycontrol 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

Chemist C is responsible for analysis, review, and investigation. He is also responsible for maintaining the GPL in the laboratory.

Responsibilities

• 1. Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.
• 2. Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.
• 3. Independently plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction.
• 4. Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.
• 5. Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.
• 6. Perform maintenance and calibrations of laboratory instruments/equipments with supervisory direction/training.
• 7. Perform troubleshooting and investigations under the direction of a supervisor.
• 8. Comply with all regulatory/in-house requirements (may include but not limited to safety, house keeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity.
• 9. Review of Analytical documents
• 10. Investigation
• 11. Maintain GLP in laboratory.
• 12. QAMS document handling.
• 13. Other resposibilities assigned by reporting manager.

Qualifications - Skills & Requirements

• Minimum BS with Scientific field
• BS with Chemistry is one of the subjects would be preferable
• Minimum 4-6 years experience in pharmaceuticals and must have 3-5 year experience in Analytical testing
• 3 years QC experience in Generic Pharmaceutical industries would be preferable
• Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA
• Ability to learn quickly and decision making skills

Education & Experience

• Minimum BS with Scientific field
• BS with Chemistry is one of the subjects would be preferable
• Minimum 4-6 years experience in pharmaceuticals and must have 3-5 year experience in Analytical testing
• 3 years QC experience in Generic Pharmaceutical industries would be preferable

Compensation

• Min: USD $80,000.00/Yr.
• Max: USD $90,000.00/Yr.

Physical Requirements

FIELD - While performing the duties of this job the employee is required to:

• Work in a temperature controlled office environment or travel via vehicle or commercial transportation
• While performing the duties of this job, the employee is occasionally required to handle or feel objects, talk, hear, and walk during the course of employment
• Position requires some degree of travel for business purposes Employee may use computer, phone, copier and other office equipment in the course of a day
• Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and an ability to adjust focus Sedentary work Exerting up to 10 pounds of force occasionally and/or negligible amount of force frequently or constantly to lift, carry, push, pull or otherwise move objects, including the human body. Sedentary work involves sitting most of the time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

Blood/Fluid Exposure Risk

Category II: Usual tasks do not involve exposure to blood, body fluid, or tissues but job may require performing unplanned Category I tasks.