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Quality Assurance Analyst
2 months ago
Company Overview:
Aurobindo Pharma USA, Inc. is a leading entity in the pharmaceutical sector, established with a commitment to excellence in the development and manufacturing of generic medications.
The organization is supported by a seasoned management team with extensive experience in manufacturing, research and development, quality assurance, quality control, and regulatory compliance.
Our current operations include several formulations and a strong pipeline of products aimed at providing affordable healthcare solutions globally.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 in relevant fields.
Responsible for guaranteeing 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 in the analytical laboratory.Compile and analyze trends in analytical data.
Review and prepare Standard Operating Procedures (SOPs), Standard Test Procedures (STPs), Good Testing Practices (GTPs), and protocols.
Oversee the review and approval of sample logins in Laboratory Information Management Systems (LIMS) and data migration.
Qualifications - Skills & Requirements:
Experience in the generic pharmaceutical industry is preferred.
Familiarity with Good Documentation Practices, as well as knowledge of USP/ICH/FDA regulations.
Ability to learn swiftly and demonstrate sound decision-making skills.
Education & Experience:
A minimum of a Bachelor’s degree in a scientific discipline is required.
A degree in Chemistry is highly desirable.
At least 3-5 years of experience in a pharmaceutical analytical laboratory, with 1-2 years specifically in reviewing quality control data.
Physical Requirements:
This is an office-based position. While performing the duties of this role, 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 moderately noisy environment (i.e., business office with computers, phones, printers, and light traffic).
- Ability to sit at a computer terminal for extended periods. Sedentary work may involve exerting up to 10 pounds of force occasionally and/or negligible amounts of force frequently or constantly to lift, carry, push, pull, or otherwise move objects, including the human body.
Physical Requirements:
No additional requirements.
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.
Equal Opportunity Employer:
Aurobindo Pharma USA, Inc. provides equal employment opportunities to all employees and applicants, prohibiting discrimination and harassment of any kind based on 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.
