IPQA Specialist: Quality Oversight for Sterile Injectables

Global Blockchain Talent; Monroe (NC); On-site; USD 75,000 - 95,000; Full time

Job summary

Glenmark Pharmaceuticals Inc. in Monroe, NC is seeking an IPQA Specialist to provide quality support during manufacturing activities, line clearance, material staging and packaging.

The role focuses on reviewing batch documentation, ensuring cGMP compliance and supporting sterile injectable processes. You will be the SME for visual inspection of vial and syringe products, perform AQL checks, and help maintain the retentive sample program while coordinating with Production and QC.

Qualifications

• Bachelor's degree in a scientific field is required.
• Minimum 3+ years in pharmaceutical manufacturing.
• Quality experience on the manufacturing floor is preferred.

Responsibilities

• Provide quality support during manufacturing activities such as line clearance, material staging, label preparation and packaging.
• Review and compile batch records and related documentation.
• Ensure compliance with SOPs, forms, BPRs and protocols.
• Oversee visual inspection programs for sterile injectable products.
• Operate in accordance with cGMP, 21 CFR, USP, EP and ICH requirements.
• Perform periodic compliance walks through Production and Warehouse.

Skills

Quality oversight

Line clearance

AQL inspection

Documentation review

cGMP knowledge

Technical writing

Microsoft Word

Excel

Windows

Time management

Communication

Organization

Education

Bachelor’s degree in scientific discipline or closely related technical field of study

Tools

Windows

Microsoft Word

Excel

Job description

Glenmark Pharmaceuticals Inc. in Monroe, NC is seeking an IPQA Specialist to provide quality support during manufacturing activities, line clearance, material staging and packaging.

The role focuses on reviewing batch documentation, ensuring cGMP compliance and supporting sterile injectable processes. You will be the SME for visual inspection of vial and syringe products, perform AQL checks, and help maintain the retentive sample program while coordinating with Production and QC.