Aurobindo Pharma USA, Inc.

CHEMIST A/METROLOGIST

Job Locations US-NJ-East Windsor
ID
2021-2692
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.  

Job Overview

  • Responsible for QC activity including calibration, PM/Troubleshooting 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.
  • Preferably having experience as meteorologist.
  • Filling of change controls 

Responsibilities

  • Incumbant will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials.
  • Effectively plan and conduct QC analytical testing using established (official and/or in-house) test procedures.
  • Execute 95% - 100% of analytical work at the bench level

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
  • 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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