Aurobindo Pharma USA, Inc.

QUALITY CONTROL ANALYST

Job Locations US-NJ-East Windsor
ID
2021-2685
Category
Lab/QC
Type
Aurolife Pharma
Status
Temporary Full-Time

Division Overview

Aurolife PharmaLLC logo

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 give 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

Chemist will perform a variety of QC testing to assess the strength, identity and purity of test samples and/or materials. The Chemist will work as a member of team to effectively plan and QC sampling, analytical testing using established (official and/or in-house) test procedures. The Chemist may execute 90% - 100% of their work at the bench level. 

Responsibilities

1. Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.

 

2. Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work.

 

3. Independently plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction.

 

4. Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately.

 

5. Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned.

 

6. Perform maintenance and calibrations of laboratory instruments/equipments with supervisory direction/training.

 

7. Perform troubleshooting and investigations under the direction of a supervisor.

 

8. 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.

 

9. Review of Analytical documents as required

Qualifications - Skills & Requirements

• Minimum BS with Scientific field

 

• BS with Chemistry is one of the subjects would be preferable

 

• Minimum 1-3 years experience in pharmaceuticals and 1-2 year experience in Analytical testing desirable

 

• QC experience in Generic Pharmaceutical industries would be preferable

 

• Knowledge in Good Documentation practices. Knowledge in USP/ICH/FDA

 

• Ability to learn quickly and decision making skills

Education & Experience

chemical tests using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Auto titrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs.

Physical Requirements

FIELD - While performing the duties of this job the employee is required to: • Work in a temperature controlled office environment or travel via vehicle or commercial transportation • While performing the duties of this job, the employee is occasionally required to handle or feel objects, talk, hear, and walk during the course of employment • Position requires some degree of travel for business purposes • Employee may use computer, phone, copier and other office equipment in the course of a day • Specific vision abilities required by the job include close vision, distance vision, color vision, peripheral vision, depth perception and an ability to adjust focus 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.

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