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 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 Chemist will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. The Chemist will work as a member of team to effectively plan and QC analytical testing using established (official and/or in-house) test procedures. The Chemist may execute 90% - 100% of their work at the bench level.
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 as required
Qualifications - Skills & Requirements • Minimum BS with Scientific field
• BS with Chemistry is one of the subjects would be preferable
• Minimum 1-3 years experience in pharmaceuticals and 1-2 year experience in Analytical testing desirable
• 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 1-3 years experience in pharmaceuticals and 1-2 year experience in Analytical testing desirable
Physical Requirements LAB TECHNICIANS - Must be able to bend at the waist and knees as well as twist at the trunk. • 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
Additional
Physical Requirements No Additional Requirements
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.
We Are An Equal Opportunity Employer
Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation, and training.
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