Quality Assurance Associate

AUROBINDO PHARMA LTD; Cranbury Township (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading global pharmaceutical company is seeking a Quality Assurance Associate. This role focuses on maintaining compliance with regulatory standards, managing QA documentation, and conducting training sessions. Ideal candidates will have a relevant degree and experience in Quality Assurance.

Qualifications

• 2-4 years of experience in Pharmaceutical Quality Assurance/Compliance.

Responsibilities

• Maintain and improve the Quality System for the US region.
• Ensure conformance to SOPs and regulations.
• Manage QA documentation review and approval processes.

Skills

Effective communication

Education

BS/BA Degree in Science or Regulatory fields

Job description

Join to apply for the Quality Assurance Associate role at AUROBINDO PHARMA LTD

Aurobindo Pharma USA, Inc., a subsidiary of Aurobindo Pharma Limited, is seeking a Quality Assurance Associate. The company is a global pharmaceutical manufacturer and distributor, committed to delivering quality, affordable generic pharmaceuticals worldwide.

Job Overview

Under the supervision of the Senior Manager, Quality and Compliance, this role involves documentation, training, and ensuring compliance with regulatory and cGMP requirements related to Change Controls, Deviations, CAPA, and supporting subsidiaries.

Responsibilities

1. Maintain and improve the Quality System for the US region.
2. Ensure conformance to SOPs, procedures, policies, and regulations (21 CFR 210-211), OSHA requirements, and safety procedures.
3. Manage QA documentation review and approval processes.
4. Handle activities related to QA documentation, training, and programs like Nichelon, DMS, and QAMS.
5. Participate in regulatory inspections and prepare documentation for audits.
6. Review content for accuracy and compliance.
7. Prepare and revise SOPs and ensure documentation effectiveness.
8. Coordinate and conduct training sessions, evaluate their effectiveness, and maintain training records.
9. Collaborate with management and training coordinators to ensure adherence to training schedules and policies.
10. Assist with other duties as assigned.

Qualifications - Skills & Requirements

• BS/BA Degree, preferably in Science or Regulatory fields.
• 2-4 years of experience in Pharmaceutical Quality Assurance/Compliance or relevant education with knowledge of cGMP regulations.
• Effective communication skills in English, with the ability to work independently and collaboratively.

Physical and Other Requirements

This is an office-based role requiring prolonged sitting, computer work, light lifting (up to 25 lbs), and adherence to safety protocols. No exposure to blood or body fluids is expected.

Equal Opportunity Statement

Aurobindo Pharma USA, Inc. is an Equal Opportunity Employer, committed to diversity and inclusion in the workplace.