Quality Assurance Associate

Aurobindo Pharma USA, Inc.; East Windsor Township (NJ); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading pharmaceutical company is seeking a Quality Assurance Specialist to ensure compliance with regulatory and cGMP requirements. This role involves managing QA documentation, conducting training, and collaborating with teams across subsidiaries. Ideal candidates will have a BSc/BA in Science and 2-4 years of experience in QA/Compliance. Join a dynamic team committed to quality and safety in pharmaceutical manufacturing.

Qualifications

• 2-4 years of experience in pharmaceutical QA/Compliance.
• Knowledge of cGMP regulations.

Responsibilities

• Maintain and improve the Quality System for the US Region.
• Manage QA documentation review and approval processes.
• Conduct and present NEO training.

Skills

Collaboration

Communication

Independence

Education

BSc/BA in Science

Job description

Division Overview

Aurobindo Pharma USA, Inc. is a generic pharmaceutical manufacturer and distributor, wholly owned by Aurobindo Pharma Limited, based in India. Founded in 1986 and headquartered in HITEC City, Hyderabad, India, it became a public company in 1992.

The company is committed to delivering a broad portfolio of quality, affordable generic pharmaceuticals, adding value through superior customer service and efficient processes. It operates in over 125 countries, with a portfolio of more than 180 product families and 450 individual packages.

Aurobindo markets over 80% of the top 100 most prescribed products worldwide and has received numerous ANDA approvals, ranking 2nd among pharmaceutical companies based on prescriptions dispensed.

Job Overview

Under the oversight of the Senior Manager, Quality and Compliance, this position is responsible for documentation and training for Aurobindo Pharma USA, ensuring compliance with regulatory and cGMP requirements related to Change Controls, Deviations, CAPA, and more. The role also supports subsidiaries of Aurobindo Pharma USA as applicable.

Responsibilities

1. Maintain and improve the Quality System for the US Region in collaboration with regional management.
2. Ensure conformance to SOPs, procedures, policies, and regulations (21 CFR 210-211), including OSHA and safety requirements.
3. Manage QA documentation review and approval processes.
4. Handle QA documentation activities related to training and documentation functions.
5. Work with programs such as Nichelon, DMS, and QAMS.
6. Ensure QA controls comply with company standards and best practices.
7. Participate in regulatory inspections and follow-up activities.
8. Assist in preparing documentation for inspections and audits.
9. Review content for accuracy and compliance during review periods.
10. Prepare, revise, and implement SOPs and other cGxP documents.
11. Maintain accuracy standards in documentation.
12. Collaborate with HR and management to identify training needs.
13. Conduct and present NEO training, manage training materials, and assess training effectiveness.
14. Coordinate annual GMP, Quality Culture, and Safety trainings with site leadership.
15. Perform other duties as assigned upon request.

Qualifications - Skills & Requirements

• BSc/BA in Science or a regulatory-related field preferred.
• 2-4 years of experience in pharmaceutical QA/Compliance or relevant education with knowledge of cGMP regulations.
• Ability to effectively collaborate across subsidiaries and teams.
• Proficiency in English communication, both written and verbal.
• Ability to work independently.
• Sedentary work capacity, including sitting at a computer for extended periods and lifting up to 25 lbs.

Education & Experience

• BSc/BA in Science or related field preferred.
• 2-4 years' experience in pharmaceutical QA/Compliance or relevant education.
• Experience with internal and external (regulatory) audits preferred.

Physical Requirements

This is an office-based role requiring sitting, standing, reaching, and light lifting. Specific vision abilities are necessary for computer work. The noise level is moderate, and the physical exertion is minimal, with occasional lifting up to 25 lbs.

Additional Physical and Exposure Risks

This position involves no exposure to blood, body fluids, or tissues (Category III risk).

Equal Opportunity Employment

Aurobindo Pharma USA, Inc. is an equal opportunity employer. Discrimination or harassment based on any characteristic protected by law is prohibited and applies to all aspects of employment.