Aurobindo Pharma USA, Inc.

CHEMIST A

Job Locations US-NJ-East Windsor
ID
2021-2699
Category
Lab/QC
Type
Aurolife Pharma
Status
Full-Time

Division Overview

Aurolife was founded in 2008 as part of a group of companies that has a long history of excelling in generic pharmaceutical product 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

  • Responsible for QC activity including calibration of all Lab instruments.
  • Unkeep all lab instruments documents and records.
  • Co-ordinate with Vendor on instrument qualification as per CGMP requirements.
  • Maintain the record of laboratory reference/working standard.
  • Maintain the calibration record of all instruments.
  • Prepare and maintain the calibration schedule and record of instruments.
  • Reponsible for testing and sampling activity.
  • Filling of change controls 

Responsibilities

  • Perform assigned sampling, physical, chemical tests and assay on raw    materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemistry, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Autotitrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.
  • Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.
  • Independently plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction.
  • Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.
  • Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.
  • Prepare the Method Transfer/Method verification protocols. Execution of the method transfer/validation/verification activities and reports preparation.
  • Perform the testing activity of all Exhibit batch’s required raw materials (Active/inactive/Packaging materials), finished product dosage forms and stability sample testing.
  • Provide the necessary document to Support for the ANDA filing.
  • Perform maintenance/minor repairs and calibrations on laboratory instruments/equipment with supervisory direction/training.
  • Perform troubleshooting and investigations under the direction of a supervisor/senior QC chemist.
  • 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

Qualifications - Skills & Requirements

  • Experience in Sterile Dosage and Generic Pharmaceutical industries would be preferable
  • Experience in a cGMP environment is required
  • Knowledge of USP/ICH/FDA guidelines
  • Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA
  • Up to 7 years of experience in pharmaceuticals and must have 5 + years of experience in Analytical testing
  • Ability to learn quickly and decision making skills

Education & Experience

  • BS in Chemistry, Pharmaceutical Sciences, or related field is preferable
  • Minimum 5+ years of experience in pharmaceuticals and must have up to 3 years of experience in Analytical testing
  • Up to 5 years QC experience in Generic Pharmaceutical industries would be preferable

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

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.

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