IPQA Associate I - Onsite QA (2nd Shift)

Sun Pharmaceutical Industries, Inc.; New Brunswick (NJ); On-site; USD 65,000 - 90,000; Full time

Job summary

Sun Pharmaceutical Industries, Inc. seeks an In-Process Quality Assurance (IPQA) Associate I to support manufacturing operations on the 2nd shift (Mon-Fri, 3:15-11:45pm) onsite in New Jersey.

The role focuses on monitoring packaging and production activities to ensure cGMP compliance, SOP adherence, and product quality, with cross-functional collaboration on quality issues. Responsibilities include line clearance, release inspections, document review, and quality system support using TrackWise

Qualifications

• Bachelor's degree in a science related major required.
• Minimum 2 years of experience in a pharmaceutical quality role.
• Experience supporting manufacturing, packaging, QA or quality systems in a regulated environment.
• English proficiency at CEFR B1+ level.

Responsibilities

• Perform routine area assessments to ensure compliance with cGMP requirements, SOPs, policies, and procedures.
• Provide line clearance authorization prior to manufacturing and packaging operations.
• Conduct conditional and final release inspections of packaging lines.
• Support and monitor in-process quality checks during manufacturing and packaging activities.
• Collaborate with Production and Packaging teams to resolve quality-related issues and ensure compliance throughout operations.
• Review and approve controlled documents, including manufacturing and packaging batch records.
• Ensure timely and accurate completion of quality-related documentation.
• Support the closure of immediate actions within TrackWise.
• Manage material status and compliance-related transactions within SAP.
• Review cleaning validation protocols and reports.
• Review process validation protocols and reports.
• Support APR data entry and compilation activities as needed.
• Assist with quality improvement initiatives and QA-related activities.

Skills

attention to detail

time management

cross-functional collaboration

communication

Education

Bachelor's degree in science

Tools

TrackWise

SAP

LMS

MS Office (Word, Excel, PowerPoint, Outlook)

Job description

Sun Pharmaceutical Industries, Inc. seeks an In-Process Quality Assurance (IPQA) Associate I to support manufacturing operations on the 2nd shift (Mon-Fri, 3:15-11:45pm) onsite in New Jersey.

The role focuses on monitoring packaging and production activities to ensure cGMP compliance, SOP adherence, and product quality, with cross-functional collaboration on quality issues. Responsibilities include line clearance, release inspections, document review, and quality system support using TrackWise