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Company Overview:
Aurobindo Pharma USA, Inc. is a leader in the pharmaceutical industry, established to deliver high-quality generic medications. With a strong foundation in manufacturing and product development, we have built a reputation for excellence in solid oral dosage forms.
Key Responsibilities:
Conduct thorough reviews of daily analytical data produced in the laboratory. Ensure that essential laboratory documentation is maintained and updated in accordance with current regulatory standards.
Compile and review analytical data necessary for regulatory submissions.
Act as a departmental representative and/or technical lead during meetings. May oversee and coordinate the daily activities of fellow chemists. Engage in discussions and meetings to share insights and ideas in relevant fields.
Responsible for verifying the accuracy of analytical measurements and ensuring compliance with USFDA and other applicable regulatory standards, cGMP, and corporate policies.
Exhibit critical thinking and creativity in problem-solving.
Prepare reports in both written and oral formats to communicate new ideas or methodologies to relevant personnel.
Participate in internal audits to ensure compliance with cGLP and cGMP standards in the Analytical Laboratory.Compile and analyze trends in analytical data.
Review and draft Standard Operating Procedures (SOPs), Standard Test Procedures (STPs), Good Testing Practices (GTPs), and protocols.
Review and approve sample logins in the Laboratory Information Management System (LIMS) and oversee data migration.
Qualifications - Skills & Requirements:
Experience in the generic pharmaceutical sector is preferred.
Familiarity with Good Documentation Practices and knowledge of USP/ICH/FDA guidelines.
Ability to learn swiftly and make informed decisions.
Education & Experience:
Bachelor's degree in Chemistry is preferred. A minimum of a Bachelor's degree in a scientific discipline is required.
At least 3-5 years of experience in a pharmaceutical analytical laboratory setting, with 1-2 years of experience in reviewing Quality Control data.
Physical Requirements:
This is an office-based position. While performing the duties of this job, the employee is required to:
- Stand, sit, talk, hear, and use hands and fingers to operate a computer and telephone keyboard, reach, stoop, and kneel to install computer equipment.
- Meet specific vision requirements due to computer work.
- Engage in light to moderate lifting.
- Work in a moderate noise environment (i.e., business office with computers, phones, printers, and light traffic).
- Be able to sit at a computer terminal for extended periods. Sedentary work involves exerting up to 10 pounds of force occasionally and/or a negligible amount of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body.
Category III:
Tasks involve no exposure to blood, body fluids, or tissues. Category I tasks are not a condition of employment.
Equal Opportunity Employer:
Aurobindo Pharma USA, Inc. is committed to providing equal employment opportunities to all employees and applicants, prohibiting discrimination and harassment of any kind 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.
