Quality Control Reviewer - Aurobindo Pharma USA, Inc.

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.

Responsibilities:

• Review of day-to-day Analytical data generated in the Laboratory. Maintains and updates essential Laboratory documents as per current regulatory guidelines.
• Review and Compilation of Analytical Data required for Regulatory filings.
• Serves as department representative and/or technical lead at meetings. May lead and coordinate day-to-day activities of other chemists. Participates in discussions and meetings for the purpose of exchanging ideas in relevant areas of interest.
• Accountable for ensuring that the analytical measurements are accurate and that methods are in compliance with USFDA, and/or other applicable regulatory guidelines, cGMP and corporate requirements. Expected to plan, organize and schedule the activities based on the situation.
• Demonstrates critical thinking skills and creativity when solving problems. Originates reports in written or oral form so that new ideas or approaches are brought to the attention of appropriate personnel.
• Participate periodically internal audits compliance to cGLP and cGMP in Analytical Lab.
• Compilation and trending of Analytical data.
• Review and preparation of SOPs, STPs, GTPs and Protocols.
• Review/ approval of sample login in LIMS and data migration.

Qualifications - Skills & Requirements:

• Experience in Generic Pharmaceutical industries would be preferable
• Knowledge of Good Documentation practices. Knowledge of USP/ICH/FDA
• Ability to learn quickly and decision making skills

Education & Experience:

• BS in Chemistry preferred.  Minimum BS with scientific field
• Minimum 3-5 years experience in a pharmaceutical analytical lab setting and 1-2 years experience in reviewing QC data

Physical Requirements:OFFICE 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 kneel to install computer equipment •Specific vision abilities required by this job include close vision requirements due to computer work •Light to moderate lifting is required •Moderate noise (i.e. business office with computers, phone, and printers, light traffic). •Ability to sit at a computer terminal for an extended period of time 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.Additional Physical 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.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.